Publications by authors named "Huiping Xu"

115 Publications

Phase 1 Study Evaluating the Effects of the Proton Pump Inhibitor Rabeprazole and Food on the Pharmacokinetics of Lorlatinib in Healthy Participants.

Clin Pharmacol Drug Dev 2021 Jul 20. Epub 2021 Jul 20.

Pfizer Inc., La Jolla, California, USA.

Lorlatinib is approved worldwide as treatment for anaplastic lymphoma kinase-positive and c-ros oncogene 1-positive non-small cell lung cancer. The objectives of this phase 1, open-label crossover study (NCT02569554) in healthy adult participants were to determine (1) the effects of the proton pump inhibitor (PPI) rabeprazole on lorlatinib pharmacokinetics (PK), (2) the effects of a high-fat meal on lorlatinib PK, and (3) the relative bioavailability of an oral solution to tablet formulation of lorlatinib under fasted conditions. Participants were followed on-study for ≥50 days after the first dose of lorlatinib. Participants received treatments over 4 periods, with a washout of ≥10 days between consecutive lorlatinib doses. Twenty-seven participants were enrolled and received lorlatinib, and all were assessed for PK and safety. Results showed no effect of multiple doses of rabeprazole on the total plasma exposure of a single oral dose of lorlatinib 100-mg tablets. The results also indicated that a high-fat meal had no effect on lorlatinib PK after a single 100-mg oral dose. In addition, the relative bioavailability of lorlatinib oral solution compared with lorlatinib tablets was complete (approximately 108%). The safety profile of lorlatinib was consistent with that reported in previous studies, and most treatment-related adverse events were mild to moderate. These data indicate that lorlatinib can be administered with drugs that modify gastric acid, including PPIs, without restriction. These results also confirm that lorlatinib can be administered regardless of food intake.
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http://dx.doi.org/10.1002/cpdd.1000DOI Listing
July 2021

Observation of negative capacitance in antiferroelectric PbZrO Films.

Nat Commun 2021 Jul 9;12(1):4215. Epub 2021 Jul 9.

Key Laboratory of Advanced Materials (MOE), School of Materials Science and Engineering, Beijing Innovation Center for Future Chip (ICFC), Tsinghua University, Beijing, China.

Negative capacitance effect in ferroelectric materials provides a solution to the energy dissipation problem induced by Boltzmann distribution of electrons in conventional electronics. Here, we discover that besides ferroelectrics, the antiferroelectrics based on Landau switches also have intrinsic negative capacitance effect. We report both the static and transient negative capacitance effect in antiferroelectric PbZrO films and reveal its possible physical origin. The capacitance of the capacitor of the PbZrO and paraelectric heterostructure is demonstrated to be larger than that of the isolated paraelectric capacitor at room temperature, indicating the existence of the static negative capacitance. The opposite variation trends of the voltage and charge transients in a circuit of the PbZrO capacitor in series with an external resistor demonstrate the existence of transient negative capacitance effect. Strikingly, four negative capacitance effects are observed in the antiferroelectric system during one cycle scan of voltage pulses, different from the ferroelectric counterpart with two negative capacitance effects. The polarization vector mapping, electric field and free energy analysis reveal the rich local regions of negative capacitance effect with the negative dP/dE and (δG)⁄(δD), producing stronger negative capacitance effect. The observation of negative capacitance effect in antiferroelectric films significantly extends the range of its potential application and reduces the power dissipation further.
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http://dx.doi.org/10.1038/s41467-021-24530-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8270919PMC
July 2021

Underperformance of Contemporary Phase III Oncology Trials and Strategies for Improvement.

J Natl Compr Canc Netw 2021 06 21:1-7. Epub 2021 Jun 21.

Richard A. and Susan F. Smith Cancer Center for Outcomes Research in Cardiology, Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center.

Background: Statistical testing in phase III clinical trials is subject to chance errors, which can lead to false conclusions with substantial clinical and economic consequences for patients and society.

Methods: We collected summary data for the primary endpoints of overall survival (OS) and progression-related survival (PRS) (eg, time to other type of event) for industry-sponsored, randomized, phase III superiority oncology trials from 2008 through 2017. Using an empirical Bayes methodology, we estimated the number of false-positive and false-negative errors in these trials and the errors under alternative P value thresholds and/or sample sizes.

Results: We analyzed 187 OS and 216 PRS endpoints from 362 trials. Among 56 OS endpoints that achieved statistical significance, the true efficacy of experimental therapies failed to reach the projected effect size in 33 cases (58.4% false-positives). Among 131 OS endpoints that did not achieve statistical significance, the true efficacy of experimental therapies reached the projected effect size in 1 case (0.9% false-negatives). For PRS endpoints, there were 34 (24.5%) false-positives and 3 (4.2%) false-negatives. Applying an alternative P value threshold and/or sample size could reduce false-positive errors and slightly increase false-negative errors.

Conclusions: Current statistical approaches detect almost all truly effective oncologic therapies studied in phase III trials, but they generate many false-positives. Adjusting testing procedures in phase III trials is numerically favorable but practically infeasible. The root of the problem is the large number of ineffective therapies being studied in phase III trials. Innovative strategies are needed to efficiently identify which new therapies merit phase III testing.
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http://dx.doi.org/10.6004/jnccn.2020.7690DOI Listing
June 2021

Early adverse life events and post-traumatic stress disorder in patients with constipation and suspected disordered defecation.

Neurogastroenterol Motil 2021 Jun 14:e14195. Epub 2021 Jun 14.

Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.

Background: Early adverse life events (EALs) and post-traumatic stress disorder (PTSD) are associated with irritable bowel syndrome (IBS). Disordered defecation (DD) presents with symptoms of IBS or functional constipation (FC) and is associated with psychological distress. However, the role of trauma and stress in chronic constipation is poorly defined. We aimed to examine EALS, PTSD, and psychological symptoms in patients with constipation and suspected DD.

Methods: We conducted a survey study among adults with constipation who completed anorectal manometry (ARM) and balloon expulsion testing (BET). Data were collected on socio-demographics, EALs, PTSD, bowel symptoms, quality of life, and anxiety and depression. We performed comparisons between individuals with normal versus abnormal ARM or BET, subgroup analysis by detailed ARM and BET findings, and latent class analysis using individual EAL domains.

Key Results: Among 712 eligible patients, 69 completed the study. EALs and provisional PTSD were present in 75.4% and 27.5%, respectively; rates did not differ between those with normal versus abnormal ARM or BET. Normal testing was associated with higher rates of specific EAL domains (emotional abuse and mental illness), higher depression scores, and poorer mental component scores in both primary and subgroup comparisons (all p < 0.05). Normal testing was associated with a lower likelihood of high-EAL latent class (p = 0.01) membership. Presence of IBS or FC did not influence associations.

Conclusions & Inferences: Early adverse life events and PTSD are prevalent in patients with constipation and suspected DD. Those with normal ARM and BET have higher rates of prior emotional abuse and poorer mental health.
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http://dx.doi.org/10.1111/nmo.14195DOI Listing
June 2021

Peer recovery services for persons returning from prison: Pilot randomized clinical trial investigation of SUPPORT.

J Subst Abuse Treat 2021 07 27;126:108339. Epub 2021 Feb 27.

Department of Biostatistics, School of Medicine, Indiana University, 410 W. 10th St., Indianapolis, IN 46202, United States of America. Electronic address:

Previously incarcerated persons with substance use disorder (SUD) need recovery supports, given the overrepresentation of this population in prison and community supervision. Peer support programs have the potential to fill gaps in postrelease support for persons with SUD. To assess the effectiveness of peer support approaches, this pilot study randomized access to peer recovery coaches within a well-established community reentry program. We examined several proximal outcomes to determine potential mechanisms of action, along with several exploratory outcomes. While attrition due to re-incarceration, death, and program disengagement was high, our findings suggest that those who received peer recovery coach support in the reentry program had recovery-based improvements, including improved self-reported mental and physical health and reductions in substance use behaviors. The treatment group also saw improvements in measures of treatment motivation and self-efficacy. Both groups saw similar positive trends in some outcomes, likely due to the relative success of the well-established reentry program regardless of the inclusion of peer support coaches. This study contributes lessons learned and potential mechanisms of action to limited research on the effectiveness of peer recovery supports for reentry populations with SUD.
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http://dx.doi.org/10.1016/j.jsat.2021.108339DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8248907PMC
July 2021

Structure with thin SiO/SiN bilayer and Al electrodes for high-frequency, large-coupling, and low-cost surface acoustic wave devices.

Ultrasonics 2021 Aug 17;115:106460. Epub 2021 May 17.

Key Laboratory of Advanced Materials (MOE), School of Materials Science and Engineering, Tsinghua University, Beijing 100084, China. Electronic address:

With the development of fifth-generation wireless systems, the Internet of Things, and health services, surface acoustic wave (SAW)-based filters and sensors have attracted considerable interest. This study presents a new structure for high-frequency, large-coupling, and low-cost SAW devices that helps implement high-frequency and wideband filters and enhances the sensitivity of sensors. The structure is based on 15°Y-X LiNbO, thin SiO/SiN bilayer overlay, and Al electrodes. Furthermore, a low-cost fabrication process for SAW devices based on this structure was designed. Simulation and experimental results show that the bilayer substantially weakens the leaky nature of shear-horizontal-type SAWs with a phase velocity higher than that of a slow-shear bulk wave in LiNbO. Thus, the limitation related to the velocity of 4029 m/s was overcome, and the phase velocity reached approximately 4500 m/s, which means an increase of 50% compared with that of conventional Cu/15°Y-X LiNbO devices. Consequently, the frequency dramatically increases, and the quality of the SAW response is ensured. Simultaneously, a large electromechanical coupling factor close to 20% can be achieved, which is still suitable for wideband filters and sensors with high energy transduction coefficients. This new structure is expected to become a major candidate for SAW devices in the future.
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http://dx.doi.org/10.1016/j.ultras.2021.106460DOI Listing
August 2021

Short-chain fatty acid and fecal microbiota profiles are linked to fibrosis in primary biliary cholangitis.

FEMS Microbiol Lett 2021 04;368(6)

Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN 46202, USA.

The gut microbiota and metabolome could play a role in primary biliary cholangitis (PBC) progression. We aimed to assess fecal microbiota and fecal short-chain fatty acids (SCFAs) in PBC according to fibrosis. In a cross-sectional study of 23 PBC patients, fecal microbiota and SCFAs were determined using 16S rRNA sequencing and nuclear magnetic resonance spectroscopy, respectively. Fecal acetate and SCFAs were higher in advanced fibrosis. Advanced fibrosis microbiota exhibited decreased alpha diversity, increased Weisella and a distinct community composition. SCFAs correlated with individual taxa in non-advanced fibrosis. Fecal microbiota and SCFAs correspond to fibrosis in PBC.
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http://dx.doi.org/10.1093/femsle/fnab038DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8062329PMC
April 2021

Associations of Habitual Dietary Intake With Fecal Short-Chain Fatty Acids and Bowel Functions in Irritable Bowel Syndrome.

J Clin Gastroenterol 2021 Mar 12. Epub 2021 Mar 12.

*Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine ‡Department of Biostatistics; Indiana University School of Medicine, Indianapolis, IN †Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN.

Background & Goals: Diet may contribute to symptoms of irritable bowel syndrome (IBS) and luminal production of putative IBS biomarkers including short-chain fatty acids (SCFAs). Study aims were to to assess relationships of habitual fiber or starch intake with fecal SCFAs in patients with IBS and healthy volunteers (HVs).

Study: In 18 HVs and 30 patients with IBS (13 constipation-predominant [IBS-C] and 17 diarrhea-predominant [IBS-D]), habitual diet using a food frequency questionnaire; bowel functions using a validated bowel diary; and fecal SCFAs by HPLC-mass spectrometry were assessed. Associations of fiber and starch with SCFAs were analyzed using Spearman (rs) and Pearson (R) correlations. Relationships between other dietary endpoints, SCFAs, and bowel functions were explored.

Results: Habitual fiber or starch intakes were not significantly correlated with SCFAs or bowel functions in all participants or HVs nor with SCFAs in IBS. Starch was negatively correlated (R=-0.53; P=0.04) with complete evacuation in IBS-D. Fiber (rs=0.65; P=0.02) and starch (rs=0.56; P=0.05) were correlated with ease of passage in IBS-C. Stool form, frequency, and ease of passage were positively correlated with total SCFAs (all P<0.05), acetate (all P<0.01), propionate (all P<0.05), and butyrate (form P=0.01; ease of passage P=0.05) among all participants, but not in IBS. Complete evacuation was negatively correlated with propionate (R=-0.34; P=0.04) in all participants. Total (P=0.04) and individual SCFAs (all P<0.05) were positively correlated with stool form in HVs.

Conclusions: Habitual fiber and starch intake does not influence fecal SCFAs but may influence bowel functions in IBS. Fecal SCFAs correlate with bowel functions among all participants including HVs.
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http://dx.doi.org/10.1097/MCG.0000000000001521DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8435047PMC
March 2021

Potential Benefit With Complementary and Alternative Medicine in Irritable Bowel Syndrome: A Systematic Review and Meta-analysis.

Clin Gastroenterol Hepatol 2021 08 19;19(8):1538-1553.e14. Epub 2020 Sep 19.

Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana. Electronic address:

Background & Aims: Patients with irritable bowel syndrome (IBS) may pursue complementary and alternative medicine (CAM). We conducted a comprehensive systematic review and meta-analysis examining efficacy of CAM vs. placebo or sham in adults with IBS.

Methods: Publication databases were searched for randomized controlled trials of CAM therapies (herbal therapy, dietary supplements, mind-body based, body-based, and energy-healing) in adults with IBS. Data were extracted to obtain pooled estimates of mean improvement in abdominal pain (standardized mean difference [SMD]) and relative risk (RR) of overall response using random effects models. Sensitivity and subgroup analyses along with quality assessments were completed.

Results: Among 2825 articles identified, 66 were included. Herbal therapy (SMD=0.47, 95% CI: 0.20 to 0.75, I=82%) demonstrated significant benefit over placebo for abdominal pain (low confidence in estimates). Benefit with mind-body based therapy for abdominal pain was of borderline significance (SMD=0.29, 95% CI: -0.01 to 0.59, I=78%). Herbal therapy (RR=1.57, 95% CI: 1.31 to 1.88, I=77%), dietary supplements (RR=1.95, 95% CI: 1.02 to 3.73, I=75%), and mind-body based therapy (RR=1.67, 95% CI: 1.13 to 2.49, I=63%) showed benefit for overall response compared to placebo (low confidence in estimates). Body-based and energy healing therapies demonstrated no significant benefit over placebo or sham for abdominal pain or overall response.

Conclusions: CAM therapies such as herbal or dietary supplements and mind-body based approaches may be beneficial for abdominal pain and overall response in IBS. However, overall quality of evidence is low. Rigorous, high quality clinical trials are warranted to investigate CAM in IBS.
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http://dx.doi.org/10.1016/j.cgh.2020.09.035DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8112831PMC
August 2021

High prevalence of food intolerances among US internet users.

Public Health Nutr 2021 02 14;24(3):531-535. Epub 2020 Sep 14.

Division of Gastroenterology and Hepatology, Department of Medicine, 702 Rotary Circle, Suite 225, Indiana University School of Medicine, Indianapolis, IN46202, USA.

Objective: Food intolerances are commonly reported and are predicted to have gastrointestinal health implications. We aimed to quantify the prevalence of food intolerances among US adults and identify culprit foods through a brief web-based survey.

Design: We invited participation in an online cross-sectional survey involving a single questionnaire. Data were summarised using percentages or medians and interquartile range. Participant characteristics by self-reported food intolerance were compared using the Wilcoxon rank sum test and Pearson's χ2 test. Adjusted analyses were performed using multivariable logistic regression.

Setting: The survey was internet-based via Amazon's mechanical Turk, a crowdsourcing website for the completion of requester directed tasks.

Participants: Adults who were US-based internet users were invited at ages 18-80.

Results: We collected 2133 survey responses (ages 18-79 years). The rate of food intolerance was 24·8 % (95 % CI 23·0, 26·6) in US adults. Younger (P < 0·01), female (P = 0·05) and Asian, African American or multiple race individuals (P < 0·01) predominated. Lactose intolerance was most common. Frequency of a non-lactose food intolerance was 18·1 % (95 % CI 16·5, 19·8). When categorised broadly, grains, fruit, lactose, fish, vegetables, alcohol and nuts were most troublesome for individuals in that order.

Conclusions: Self-reported food intolerance is common in US internet users. The effect of food on gastrointestinal symptoms and avoidant behaviours deserves further attention.
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http://dx.doi.org/10.1017/S1368980020003298DOI Listing
February 2021

Correction to: The Effect of Rifampin on the Pharmacokinetics and Safety of Lorlatinib: Results of a Phase One, Open-Label, Crossover Study in Healthy Participants.

Adv Ther 2020 Nov;37(11):4754

Global Product Development, Clinical Pharmacology, Pfizer Oncology, La Jolla, CA, USA.

In the original article, the reference 4 has been published and cited incorrectly.
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http://dx.doi.org/10.1007/s12325-020-01480-1DOI Listing
November 2020

Incidence and Risk Factors of Recurrent Clostridioides difficile Infection in Patients With Cirrhosis.

Clin Transl Gastroenterol 2020 07;11(7):e00189

Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.

Introduction: Clostridioides difficile infection (CDI) is common in patients with cirrhosis and is associated with poor outcomes. CDI risk factors in this population have been well characterized; however, risk factors of recurrent CDI (R-CDI) after treatment have not been explored. We sought to estimate the incidence of R-CDI and its associated risk factors in patients with cirrhosis.

Methods: We performed a cohort study of patients with cirrhosis hospitalized with CDI between 2012 and 2016. We collected patient characteristics, including detailed information on the CDI, features of the underlying liver disease, and outcomes including R-CDI, hospital readmission, and mortality. R-CDI was defined as CDI occurring 2-8 weeks after the initial episode. Cox proportional hazards model was used to identify variables independently associated with the outcomes.

Results: A total of 257 hospitalized patients with cirrhosis and CDI were included. CDI was community associated in 22.6%. The incidence of R-CDI was 11.9%. R-CDI was not significantly associated with medications at hospital admission or discharge. Independent risk factors of R-CDI included increased Charlson Comorbidity Index (hazard ratio [HR] 1.30; 95% confidence interval [CI]: 1.09-1.55) and use of lactulose (HR 2.58; 95% CI: 1.09-6.09). The 30-day readmission rate was 37%, and readmission was associated with increased Charlson Comorbidity Index (HR 1.12; 95% CI: 1.03-1.23) and Model for End-Stage Liver Disease score (HR 1.04; 95% CI: 1.01-1.07). The 90-day mortality was 22.8%.

Discussion: In patients with cirrhosis, R-CDI is associated with comorbidity burden and lactulose use. Attention to these factors might aid clinicians in efforts to prevent R-CDI and improve outcomes in this population.
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http://dx.doi.org/10.14309/ctg.0000000000000189DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7384668PMC
July 2020

Fecal Microbiota Transplantation Is Safe and Effective in Patients With Clostridioides difficile Infection and Cirrhosis.

Clin Gastroenterol Hepatol 2021 08 6;19(8):1627-1634. Epub 2020 Jul 6.

Division of Gastroenterology, Indiana University School of Medicine, Indianapolis, Indiana. Electronic address:

Background & Aims: Clostridioides difficile infection (CDI) harms a large proportion of patients with cirrhosis. Fecal microbiota transplantation (FMT) is recommended for recurrent CDI, but its effects in patients with cirrhosis have not been established. We performed a multicenter observational study to evaluate the efficacy and safety of FMT for CDI in patients with cirrhosis.

Methods: We performed a retrospective study of 63 adults with cirrhosis (median model for end-stage liver disease score, 14.5; 24 patients with decompensated cirrhosis) who underwent FMT for CDI from January 2012 through November 2018 at 8 academic centers in the United States, Canada, and Italy. We collected data on patient demographics and characteristics of cirrhosis, CDI, and FMT from medical records and compared differences among patients with different severities of cirrhosis, and FMT successes vs failures at the 8-week follow-up evaluation. We also obtained data on adverse events (AEs) and severe AEs within 12 weeks of FMT.

Results: Patients underwent FMT for recurrent CDI (55 of 63; 87.3%), severe CDI (6 of 63; 9.5%), or fulminant CDI (2 of 63; 3.2%) primarily via colonoscopy (59 of 63; 93.7%) as outpatients (47 of 63; 76.8%). FMT success was achieved for 54 patients (85.7%). Among FMT failures, a higher proportion used non-CDI antibiotics at the time of FMT (44.4% vs 5.6%; P < .001), had Child-Pugh scores of B or C (100% vs 37.7%; P < .001), used probiotics (77.8% vs 24.1%; P = .003), had pseudomembranes (22.2% vs 0; P = .018), and underwent FMT as inpatients (45.5% vs 19%; P = .039), compared with FMT successes. In multivariable analysis, use of non-CDI antibiotics at the time of FMT (odds ratio, 17.43; 95% CI, 2.00-152.03; P = .01) and use of probiotics (odds ratio, 11.9; 95% CI, 1.81-78.3; P = .01) were associated with a greater risk of FMT failure. FMT-related AEs occurred in 33.3% of patients (21 of 63)-most were self-limited abdominal cramps or diarrhea. There were only 5 severe AEs that possibly were related to FMT; none involved infection or death.

Conclusions: In a retrospective study, we found FMT to be safe and effective for the treatment of CDI in patients with cirrhosis.
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http://dx.doi.org/10.1016/j.cgh.2020.06.051DOI Listing
August 2021

Longitudinal Development of Executive Functioning and Spoken Language Skills in Preschool-Aged Children With Cochlear Implants.

J Speech Lang Hear Res 2020 04 23;63(4):1128-1147. Epub 2020 Mar 23.

DeVault Otologic Research Laboratory, Department of Otolaryngology, Indiana University School of Medicine, Indianapolis.

Purpose Auditory deprivation has downstream effects on the development of language and executive functioning (EF) in prelingually deaf children with cochlear implants (CIs), but little is known about the very early development of EF during preschool ages in children with CIs. This study investigated the longitudinal development of EF and spoken language skills in samples of children with normal hearing (NH; = 40) or CIs ( = 41) during preschool ages. Method Participants were enrolled in the study between ages 3 and 6 years and evaluated annually up to the age of 7 years. Mixed-effects models were used to evaluate and predict growth of spoken language and EF skills over time. Results Children with CIs scored lower than NH peers on language measures but improved significantly over time. On performance-based neurocognitive measures of controlled attention, inhibition, and working memory, children with CIs scored more poorly than the sample of NH peers but comparable to norms, whereas on a parent report behavior checklist, children with CIs scored more poorly than both NH peers and norms on inhibition and working memory. Children with CIs had poorer EF than the sample of NH peers in most domains even after accounting for language effects, and language predicted only the verbal working memory domain of EF. In contrast, EF skills consistently predicted language skills at subsequent visits. Conclusions Findings demonstrate that, despite significant improvement over time, some domains of EF (particularly parent-reported EF) and language skills in children with CIs lag behind those of children with NH during preschool ages. Language delays do not fully explain differences in EF development between children with CIs and NH peers during preschool ages, but EF skills predict subsequent language development in children with CIs.
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http://dx.doi.org/10.1044/2019_JSLHR-19-00247DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242982PMC
April 2020

Risk Factors that Predict the Failure of Multiple Fecal Microbiota Transplantations for Clostridioides difficile Infection.

Dig Dis Sci 2021 01 13;66(1):213-217. Epub 2020 Mar 13.

Division of Gastroenterology and Hepatology, Indiana University, Indianapolis, IN, USA.

Background: Fecal microbiota transplantation (FMT) is a highly effective therapy for recurrent Clostridioides difficile infection (CDI); however, a small percentage of patients fail to achieve cure even after two FMTs. This high-risk cohort remains poorly understood.

Methods: We performed a multicenter, multinational retrospective review of patients that underwent at least one FMT for a CDI indication at four academic FMT referrals. Patients' data including CDI, FMT, and FMT variables were assessed. The primary outcome was FMT failure after a second FMT defined as persistent diarrhea and positive laboratory test for C. difficile (PCR or toxin) despite a second FMT within 8 weeks of the first FMT. A multivariable logistic regression model was performed to determine predictors of second FMT failure.

Results: A total of 540 patients received at least one FMT during the study period, of which 432 patients had success following the first FMT, 108 had documented failure (25%). Among those who failed the first FMT, 63 patients received a second FMT, of which 36 achieved cure, and 24 had documented failure after the second FMT. Patients that failed the first FMT but did not receive a second FMT and those lost to follow-up were excluded leaving 492 patients included in the analysis. The second FMT failure rate was 4.8% (24/492). Risk factors for second FMT failure identified by multivariable logistic regression included: inpatient status (OR 7.01, 95% CI: 2.37-20.78), the presence of pseudomembranes (OR 3.53, 95% CI: 1.1-11.33), and immunocompromised state (OR 3.56, 95% CI: 1.45-8.72) at the time of first FMT.

Conclusion: This study identifies clinically relevant risk factors predictive of failing a second FMT. Clinicians can use these variables to help identify high-risk patients and provide a better-informed consent regarding the possibility of needing multiple FMTs.
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http://dx.doi.org/10.1007/s10620-020-06198-2DOI Listing
January 2021

Effects of Sulfamethoxazole and 2-Ethylhexyl-4-Methoxycinnamate on the Dissimilatory Nitrate Reduction Processes and NO Release in Sediments in the Yarlung Zangbo River.

Int J Environ Res Public Health 2020 03 11;17(6). Epub 2020 Mar 11.

Water Conservancy Project & Civil Engineering College, Tibet Agriculture & Animal Husbandry University, Linzhi 860000, China.

The nitrogen pollution of rivers as a global environmental problem has received great attentions in recent years. The occurrence of emerging pollutants in high-altitude rivers will inevitably affect the dissimilatory nitrate reduction processes. In this study, sediment slurry experiments combined with N tracer techniques were conducted to investigate the influence of pharmaceutical and personal care products (alone and in combination) on denitrification and the anaerobic ammonium oxidation (anammox) process and the resulting NO release in the sediments of the Yarlung Zangbo River. The results showed that the denitrification rates were inhibited by sulfamethoxazole (SMX) treatments (1-100 μg L) and the anammox rates decreased as the SMX concentrations increased, which may be due to the inhibitory effect of this antibiotic on nitrate reducing microbes. 2-Ethylhexyl-4-methoxycinnamate (EHMC) impacted nitrogen transformation mainly though the inhibition of the anammox processes. SMX and EHMC showed a superposition effect on the denitrification processes. The expression levels of the denitrifying functional genes and were decreased and NO release was stimulated due to the presence of SMX and/or EHMC in the sediments. To the best of our knowledge, this study is the first to report the effects of EHMC and its mixtures on the dissimilatory nitrate reduction processes and NO releases in river sediments. Our results indicated that the widespread occurrence of emerging pollutants in high-altitude rivers may disturb the nitrogen transformation processes and increase the pressure of global warming.
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http://dx.doi.org/10.3390/ijerph17061822DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7143930PMC
March 2020

Delayed Gastric Emptying Is Not Associated with a Microbiological Diagnosis of Small Intestinal Bacterial Overgrowth.

Dig Dis Sci 2021 01 2;66(1):160-166. Epub 2020 Mar 2.

Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, 702 Rotary Circle, Ste 225, Indianapolis, IN, 46202, USA.

Background: Clinical symptoms of patients with small intestinal bacterial overgrowth (SIBO) may overlap with symptoms of gastroparesis. Prior studies suggest delayed small intestinal transit is associated with SIBO, but have not shown an association between delayed gastric emptying and SIBO. However, these studies have generally relied on the indirect method of breath testing to diagnose SIBO.

Aims: The aim of this study was to examine the association between a microbiological diagnosis of SIBO and delayed gastric emptying by scintigraphy.

Methods: In a single-center retrospective study of previous research participants who presented for small bowel enteroscopy for diagnostic evaluation of SIBO, we identified 73 participants who underwent gastric emptying study by scintigraphy. A microbiological diagnosis of SIBO was made in patients based on culture results of jejunal aspirates. Clinical symptoms were assessed using the total gastroparesis cardinal symptom index (GCSI) score. We compared delayed gastric emptying, 2- and 4-h gastric retention, and gastroparesis symptoms between patients with and without a microbiological diagnosis of SIBO.

Key Results: Among 29 participants with SIBO and 44 without SIBO, 33 (45%) had evidence of delayed gastric emptying. There was no significant association between a microbiological diagnosis of SIBO and delayed gastric emptying by scintigraphy. Percent retained at 2 and 4 h, and total GCSI scores did not differ significantly between those with and without SIBO.

Conclusions: Although delayed gastric emptying is common in patients with suspected SIBO, gastric emptying is not associated with a microbiological diagnosis of SIBO.
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http://dx.doi.org/10.1007/s10620-020-06153-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8048091PMC
January 2021

Depressive symptom severity as a predictor of attendance in the HOME behavioral weight loss trial.

J Psychosom Res 2020 Feb 15;131:109970. Epub 2020 Feb 15.

Department of Psychology, Indiana University-Purdue University Indianapolis (IUPUI), United States of America. Electronic address:

Objective: We examined whether total depressive symptoms and symptom clusters predicted behavioral weight loss attendance among economically disadvantaged adults in a randomized controlled trial.

Methods: 150 adults with obesity were randomized to 12 months of in-person, video conference, or enhanced usual care weight loss groups. We categorized percent session attendance in the intervention arms into three levels: no attendance, poorer attendance, and better attendance.

Results: Higher baseline Patient Health Questionnaire-8 (PHQ-8) score was associated with a greater odds of being in the poorer versus better attendance group (OR = 1.94, 95% CI: 1.02-3.69, p = .04). A similar relationship between PHQ-8 score and odds of being in the no attendance versus better attendance group was observed but was not statistically significant (OR = 1.63, 95% CI: 0.94-2.81, p = .08). Both cognitive/affective and somatic clusters contributed to the depressive symptoms-attendance relationships.

Conclusion: Greater depressive symptoms at the start of a behavioral weight loss program may predict poorer subsequent session attendance. Screening for and addressing depression may improve intervention uptake. ClinicalTrials.gov Identifier: NCT02057952.
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http://dx.doi.org/10.1016/j.jpsychores.2020.109970DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7429242PMC
February 2020

Fecal Microbiota Transplant Decreases Mortality in Patients with Refractory Severe or Fulminant Clostridioides difficile Infection.

Clin Gastroenterol Hepatol 2020 09 8;18(10):2234-2243.e1. Epub 2020 Jan 8.

Division of Gastroenterology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana. Electronic address:

Background & Aims: Fecal microbiota transplantation (FMT) is recommended for recurrent Clostridioides difficile infection (CDI). FMT cures nearly 80% of patients with severe or fulminant CDI (SFCDI) when utilized in a sequential manner. We compared outcomes of hospitalized patients before and after implementation of an FMT program for SFCDI and investigated whether the changes could be directly attributed to the FMT program.

Methods: We performed a retrospective analysis of characteristics and outcomes of patients hospitalized for SFCDI (430 hospitalizations) at a single center, from January 2009 through December 2016. We performed subgroup analyses of 199 patients with fulminant CDI and 110 patients with refractory SFCDI (no improvement after 5 or more days of maximal anti-CDI antibiotic therapy). We compared CDI-related mortality within 30 days of hospitalization, CDI-related colectomy, length of hospital stay, and readmission to the hospital within 30 days before (2009-2012) vs after (2013-2016) implementation of the inpatient FMT program.

Results: CDI-related mortality and colectomy were lower after implementation of the FMT program. Overall, CDI-related mortality was 10.2% before the FMT program was implemented vs 4.4% after (P = .02). For patients with fulminant CDI, CDI-related mortality was 21.3% before the FMT program was implemented vs 9.1% after (P = .015). For patients with refractory SFCDI, CDI-related mortality was 43.2% before the FMT program vs 12.1% after (P < .001). The FMT program significantly reduced CDI-related colectomy in patients with SFCDI (6.8% before vs 2.7% after; P = .041), in patients with fulminant CDI (15.7% before vs 5.5% after; P = .017), and patients with refractory SFCDI (31.8% vs 7.6%; P = .001). The effect of FMT program implementation on CDI-related mortality remained significant for patients with refractory SFCDI after we accounted for the underlying secular trend (odds ratio, 0.09 for level change; P = .023).

Conclusions: An FMT program significantly decreased CDI-related mortality among patients hospitalized with refractory SFCDI.
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http://dx.doi.org/10.1016/j.cgh.2019.12.029DOI Listing
September 2020

An Underwater Image Enhancement Method for Different Illumination Conditions Based on Color Tone Correction and Fusion-Based Descattering.

Sensors (Basel) 2019 Dec 16;19(24). Epub 2019 Dec 16.

Institute of Deep-Sea Science and Engineering, Chinese Academy of Sciences, Hainan 572000, China.

In the shallow-water environment, underwater images often present problems like color deviation and low contrast due to light absorption and scattering in the water body, but for deep-sea images, additional problems like uneven brightness and regional color shift can also exist, due to the use of chromatic and inhomogeneous artificial lighting devices. Since the latter situation is rarely studied in the field of underwater image enhancement, we propose a new model to include it in the analysis of underwater image degradation. Based on the theoretical study of the new model, a comprehensive method for enhancing underwater images under different illumination conditions is proposed in this paper. The proposed method is composed of two modules: color-tone correction and fusion-based descattering. In the first module, the regional or full-extent color deviation caused by different types of incident light is corrected via frequency-based color-tone estimation. And in the second module, the residual low contrast and pixel-wise color shift problems are handled by combining the descattering results under the assumption of different states of the image. The proposed method is experimented on laboratory and open-water images of different depths and illumination states. Qualitative and quantitative evaluation results demonstrate that the proposed method outperforms many other methods in enhancing the quality of different types of underwater images, and is especially effective in improving the color accuracy and information content in badly-illuminated regions of underwater images with non-uniform illumination, such as deep-sea images.
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http://dx.doi.org/10.3390/s19245567DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6960566PMC
December 2019

The Effect of Rifampin on the Pharmacokinetics and Safety of Lorlatinib: Results of a Phase One, Open-Label, Crossover Study in Healthy Participants.

Adv Ther 2020 02 20;37(2):745-758. Epub 2019 Dec 20.

Global Product Development, Clinical Pharmacology, Pfizer Oncology, La Jolla, CA, USA.

Introduction: Lorlatinib is a third-generation tyrosine kinase inhibitor approved for the treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer; cytochrome P450 (CYP) 3A plays an important role in the metabolism of lorlatinib.

Methods: This phase 1, open-label, two-period, crossover study estimated the effect of oral rifampin (a strong CYP3A inducer) on the pharmacokinetics and safety of oral lorlatinib (NCT02804399). Healthy participants received single-dose lorlatinib 100 mg in period 1 followed by rifampin 600 mg/day (days 1-12) and single-dose lorlatinib 100 mg (day 8) in period 2. Blood samples were collected for 120 h after each dose of lorlatinib.

Results: When a single dose of lorlatinib was administered during daily dosing with rifampin (period 2), the area under the plasma concentration-time profile extrapolated to infinity (AUC) and maximum plasma concentration (C) of lorlatinib were 14.74% [90% confidence interval (CI) 12.78%, 17.01%] and 23.88% (90% CI 21.58%, 26.43%), respectively, of those in period 1 (lorlatinib alone). A single dose of lorlatinib was well tolerated in period 1, but elevations in transaminase values were observed in all participants (grade 2-4 in 11 participants) within 1-3 days after a single dose of lorlatinib was administered with ongoing rifampin in period 2. Rifampin dosing was therefore halted. Transaminase levels subsequently returned to normal (median time to recovery: 15 days). No elevations in bilirubin were observed.

Conclusions: The addition of a single dose of lorlatinib to daily dosing with rifampin significantly reduced lorlatinib plasma exposure relative to a single dose of lorlatinib administered alone and was associated with severe but self-limiting transaminase elevations in all healthy participants. These observations support the contraindication in the product label against concomitant use of lorlatinib with all strong CYP3A inducers.

Trial Registration: ClinicalTrials.gov identifier, NCT02804399.
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http://dx.doi.org/10.1007/s12325-019-01198-9DOI Listing
February 2020

Variation of Suspended Particles in the Bottom Layer of the East China Sea with Data from Seafloor Observatory.

Sensors (Basel) 2019 Nov 25;19(23). Epub 2019 Nov 25.

State Key Laboratory of Marine Geology, Tongji University, 1239 Siping Road, Shanghai 200092, China.

The in situ scattering and transmissometry laser (LISST-100X), equipped with an acoustic wave and current (AWAC) meter and conductivity, temperature, and depth (CTD) instruments over the seabed in the East China Sea, was used to monitor the variation in suspended particles in the bottom sea layer, including particle size distribution (PSD) and volume concentration. The power law approximation was tested to describe the variability in PSD based on the field data. The results show that the power law was robust in processing continuous data, accompanied with the same optimal reference particle size (~63 μm) and little change in the corresponding exponent (~3.4) in both periods. Suspended particles were divided into three types: macroflocs (>133 μm), microflocs (36-133 μm), and single grains (<36 μm). Particle sizes were coarse during the two seasons, with macroflocs representing more than 60% of all the suspended particles, especially in February, when the particle size spectra were usually open-ended. Results from the harmonic analysis method indicate that tidal-induced resuspension and advection are the major reasons for the diurnal dynamics of sediments. Due to the tidal asymmetry in the region, we only found one mode in volume concentration at the moment of maximum velocity. However, the ratios of macroflocs were bimodal, with maximum floods and ebbs in one tidal cycle in February, when the higher mode at the maximum ebbs may be contributed to by the flocculation of finer particles considering the decreasing ratios of finer particles. Due to the enhanced stratification and the clean barrier built up by the Taiwan Warm Current in the southeast corner, the significant daily variation in suspended particles observed in February weakened in September. The influence of waves was uncertain, although the correlation coefficient between significant wave height and volume concentration was about 64% in February.
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http://dx.doi.org/10.3390/s19235156DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6928652PMC
November 2019

Information- and Health-care Seeking Behaviors in Patients With Irritable Bowel Syndrome.

Clin Gastroenterol Hepatol 2020 11 20;18(12):2840-2842. Epub 2019 Sep 20.

Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

Irritable bowel syndrome (IBS) is a common and clinically heterogeneous gastrointestinal disorder that can be divided into 4 subtypes: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), IBS with mixed bowel habits, and unclassified IBS. IBS decreases quality of life and imposes a substantial economic burden on the healthcare system. To develop efficient approaches to address the individual needs of IBS patients while minimizing healthcare resource overutilization, it is important to identify the factors that drive patients to seek care, to clarify the burden associated with distinct IBS subtypes, and to be aware of the resources from which IBS patients seek health-related information. We aimed to compare healthcare and information seeking between individuals with IBS-C and IBS-D.
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http://dx.doi.org/10.1016/j.cgh.2019.09.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7217611PMC
November 2020

Associations of chronic diarrhoea with non-alcoholic fatty liver disease and obesity-related disorders among US adults.

BMJ Open Gastroenterol 2019 12;6(1):e000322. Epub 2019 Aug 12.

Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.

Mechanisms explaining observed associations between diarrhoea and obesity or increased body mass index (BMI) are unclear.

Objective: To assess associations of bowel patterns with BMI, metabolic syndrome (MS), non-alcoholic fatty liver disease (NAFLD) and other obesity-related disorders.

Design: We performed a cross-sectional analysis of data from adults who completed bowel health questions for the 2005 to 2010 cycles of the National Health and Nutrition Examination Surveys. Relationships were examined using multinomial logistic regression. Confounding effects of demographics, smoking, alcohol and BMI were examined by sequential modelling.

Results: Among 13 413 adults, weighted prevalence rates of constipation and diarrhoea were 8.9% and 6.6%, respectively. Mean BMI was associated with bowel patterns (p<0.001), and was higher with diarrhoea (30.3 kg/m) versus normal bowel patterns (28.6 kg/m) and with diarrhoea versus constipation (27.8 kg/m). NAFLD was more prevalent (ORs, 95% CI) in diarrhoea versus normal bowel patterns (OR=1.34, 95% CI 1.01 to 1.78) or constipation (OR=1.45, 95% CI 1.03, 2.03) in adjusted analyses. The higher prevalence of MS in diarrhoea versus constipation (OR=1.27, 95% CI 0.97 to 1.67) was not independent of BMI.

Conclusions: These findings suggest an association between diarrhoea and NAFLD that is independent of BMI.
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http://dx.doi.org/10.1136/bmjgast-2019-000322DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6711435PMC
August 2019

MIND food and speed of processing training in older adults with low education, the MINDSpeed Alzheimer's disease prevention pilot trial.

Contemp Clin Trials 2019 09 18;84:105814. Epub 2019 Jul 18.

Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America; Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, United States of America.

Background: Multiple national organizations and leaders have called for increased attention to dementia prevention in those most vulnerable, for example persons with limited formal education. Prevention recommendations have included calls for multicomponent interventions that have the potential to improve both underlying neurobiological health and the ability to function despite neurobiological pathology, or what has been termed cognitive reserve.

Objectives: Test feasibility, treatment modifier, mechanism, and cognitive function effects of a multicomponent intervention consisting of foods high in polyphenols (i.e., MIND foods) to target neurobiological health, and speed of processing training to enhance cognitive reserve. We refer to this multicomponent intervention as MINDSpeed.

Design: MINDSpeed is being evaluated in a 2 × 2 randomized factorial design with 180 participants residing independently in a large Midwestern city. Qualifying participants are 60 years of age or older with no evidence of dementia, and who have completed 12 years or less of education. All participants receive a study-issued iPad to access the custom study application that enables participants, depending on randomization, to select either control or MIND food, and to play online cognitive games, either speed of processing or control games.

Methods: All participants complete informed consent and baseline assessment, including urine and blood samples. Additionally, up to 90 participants will complete neuroimaging. Assessments are repeated immediately following 12 weeks of active intervention, and at 24 weeks post-randomization. The primary outcome is an executive cognitive composite score. Secondary outcomes include oxidative stress, pro-inflammatory cytokines, and neuroimaging-captured structural and functional metrics of the hippocampus and cortical brain regions.

Summary: MINDSpeed is the first study to evaluate the multicomponent intervention of high polyphenol intake and speed of processing training. It is also one of the first dementia prevention trials to target older adults with low education. The results of the study will guide future dementia prevention efforts and trials in high risk populations.
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http://dx.doi.org/10.1016/j.cct.2019.105814DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6721976PMC
September 2019

Replication of an emergency department-based recovery coaching intervention and pilot testing of pragmatic trial protocols within the context of Indiana's Opioid State Targeted Response plan.

J Subst Abuse Treat 2020 01 6;108:88-94. Epub 2019 Jun 6.

Indiana University School of Medicine, Department of Emergency Medicine, 720 Eskenazi Ave., Indianapolis, IN 46202, United States of America. Electronic address:

Solving the opioid crisis requires immediate, innovative, and sustainable solutions. A number of promising strategies are being carried out by U.S. states and territories as part of their Opioid State Targeted Response (STR) plans funded through the 21st Century Cures Act, and they provide an opportunity for researchers to assess effectiveness of these interventions using pragmatic approaches. This paper describes a pilot study of Project Planned Outreach, Intervention, Naloxone, and Treatment (POINT), the intervention that served as the basis for Indiana's STR-funded, emergency department (ED)-based peer specialist expansion that was conducted in preparation for a larger, multisite pragmatic trial. Through the pilot, we identified, documented, and corrected for challenges encountered while implementing planned study protocols. Per the project's funding mechanism, the ability to move to the larger trial was determined by the achievement of 3 milestones: (1) successful replication of the intervention; (2) demonstrated ability to obtain the necessary sample size; and (3) observe a higher level of engagement in medication for addiction treatment in the POINT group compared to standard care. Overall implementation of the study protocols was successful, with only minor refinements to proposed procedures being required in light of challenges with (1) data access, (2) recruitment, and (3) identification of the expansion hospitals. All three milestones were reached. Challenges in implementing protocols and reaching milestones resulted in refinements that improved the study design overall. The subsequent trial will add to the limited but growing evidence on ED-based peer supports. Capitalizing on STR efforts to study an already scaling and promising intervention is likely to lead to faster and more sustainable results with greater generalizability than traditional, efficacy-focused clinical research.
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http://dx.doi.org/10.1016/j.jsat.2019.06.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6893113PMC
January 2020

In search of stool donors: a multicenter study of prior knowledge, perceptions, motivators, and deterrents among potential donors for fecal microbiota transplantation.

Gut Microbes 2020 23;11(1):51-62. Epub 2019 May 23.

Zeidler Ledcor Center, Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.

Fecal microbiota transplantation (FMT) is a highly effective therapy for recurrent Clostridioides difficile infection. Stool donors are essential, but difficult to recruit and retain. We aimed to identify factors influencing willingness to donate stool. This multi-center study with a 32-item questionnaire targeted young adults and health care workers via social media and university email lists in Edmonton and Kingston, Canada; London and Nottingham, England; and Indianapolis and Boston, USA. Items included baseline demographics and FMT knowledge and perception. Investigated motivators and deterrents included economic compensation, screening process, time commitment, and stool donation logistics. Logistic regression and linear regression models estimated associations of study variables with self-assessed willingness to donate stool. 802 respondents completed our questionnaire: 387 (48.3%) age 21-30 years, 573 (71.4%) female, 323 (40%) health care workers. Country of residence, age and occupation were not associated with willingness to donate stool. Factors increasing willingness to donate were: already a blood donor (OR 1.64), male, altruism, economic benefit, knowledge of how FMT can help patients (OR 1.32), and positive attitudes towards FMT (OR 1.39). Factors decreasing willingness to donate were: stool collection unpleasant (OR 0.92), screening process invasive (OR 0.92), higher stool donation frequency, negative social perception of stool, and logistics of collection/transporting feces. We conclude that 1) blood donors and males are more willing to consider stool donation; 2) altruism, economic compensation, and positive feedback are motivators; and 3) screening process, high donation frequency, logistics of collection/transporting feces, lack of public awareness, and negative social perception are deterrents. Considering these variables could maximize donor recruitment and retention.
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http://dx.doi.org/10.1080/19490976.2019.1611153DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6973337PMC
June 2020

Evaluating the effect of data standardization and validation on patient matching accuracy.

J Am Med Inform Assoc 2019 05;26(5):447-456

The Pew Charitable Trusts, Washington DC, USA.

Objective: This study evaluated the degree to which recommendations for demographic data standardization improve patient matching accuracy using real-world datasets.

Materials And Methods: We used 4 manually reviewed datasets, containing a random selection of matches and nonmatches. Matching datasets included health information exchange (HIE) records, public health registry records, Social Security Death Master File records, and newborn screening records. Standardized fields including last name, telephone number, social security number, date of birth, and address. Matching performance was evaluated using 4 metrics: sensitivity, specificity, positive predictive value, and accuracy.

Results: Standardizing address was independently associated with improved matching sensitivities for both the public health and HIE datasets of approximately 0.6% and 4.5%. Overall accuracy was unchanged for both datasets due to reduced match specificity. We observed no similar impact for address standardization in the death master file dataset. Standardizing last name yielded improved matching sensitivity of 0.6% for the HIE dataset, while overall accuracy remained the same due to a decrease in match specificity. We noted no similar impact for other datasets. Standardizing other individual fields (telephone, date of birth, or social security number) showed no matching improvements. As standardizing address and last name improved matching sensitivity, we examined the combined effect of address and last name standardization, which showed that standardization improved sensitivity from 81.3% to 91.6% for the HIE dataset.

Conclusions: Data standardization can improve match rates, thus ensuring that patients and clinicians have better data on which to make decisions to enhance care quality and safety.
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http://dx.doi.org/10.1093/jamia/ocy191DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7787357PMC
May 2019

Risk of Clostridium difficile Infection with Systemic Antimicrobial Therapy Following Successful Fecal Microbiota Transplant: Should We Recommend Anti-Clostridium difficile Antibiotic Prophylaxis?

Dig Dis Sci 2019 06 10;64(6):1668-1671. Epub 2019 Jan 10.

Division of Gastroenterology and Hepatology, Indiana University, Indianapolis, IN, USA.

Introduction: The risk of a new Clostridium difficile infection (CDI) after FMT is unknown if non-CDI antibiotics are required. It is uncertain if anti-CDI prophylaxis or probiotics would reduce risk. We therefore aimed to compare the risk of CDI with and without antibiotic exposure and the benefit of concomitant anti-CDI antibiotic or probiotic prophylaxis.

Methods: This is a multicenter retrospective study carried out at three large FMT referral centers of patients who underwent FMT for recurrent CDI. Patients were assessed for antibiotic use, as well as concomitant use of prophylactic anti-CDI antibiotics or probiotics. Time to CDI recurrence after FMT was evaluated using the Kaplan-Meier method.

Results: A total of 404 patients were included: 63% were females, with a mean age of 61.3 ± 18.8 years. Mean length of post-FMT follow-up was 18.1 ± 11.9 months (range 2.2-45.2). Among the entire cohort 8.1% (n = 33) experienced a CDI recurrence. Overall, 111 patients (27.4%) used a non-CDI antibiotic, of which 16.2% (n = 18) experienced a CDI recurrence. Patients who used non-CDI antibiotics were more likely to develop CDI (HR 8.44, 95% CI 4.21-16.93, p < 0.001). The risk of CDI recurrence was not different between patients who received anti-CDI antibiotic prophylaxis to those who did not (HR = 1.88, 95% CI 0.72-4.86, p = 0.2); however, probiotic prophylaxis was associated with a greater risk of CDI recurrence (HR = 2.65, 95% CI 1.02-6.86, p = 0.045).

Conclusion: Non-CDI antibiotic use was not uncommon after successful FMT and significantly increased the risk of a new episode of CDI. In this study, we found that the prophylactic use of anti-CDI antibiotics or probiotics was not protective.
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http://dx.doi.org/10.1007/s10620-018-5450-4DOI Listing
June 2019

Risk Factors Associated With Upper Aerodigestive Tract or Coliform Bacterial Overgrowth of the Small Intestine in Symptomatic Patients.

J Clin Gastroenterol 2020 02;54(2):150-157

Divisions of Gastroenterology and Hepatology.

Introduction: The clinical relevance of bacterial types identified in small bowel aspirate cultures during diagnostic evaluation of small intestinal bacterial overgrowth (SIBO) is unclear.

Aim: The main purpose of this study was to assess associations between risk factors for upper aerodigestive tract (UAT) or coliform SIBO and SIBO diagnosis by culture.

Materials And Methods: Small bowel aspirates were cultured in patients with suspected SIBO, defined as ≥10 colony-forming units/mL coliform or ≥10 colony-forming units/mL UAT bacteria. History was reviewed for risk factors and potential SIBO complications. Symptoms, quality of life, psychological traits, and laboratory values were assessed. We compared groups by 2-sample t test, Wilcoxon rank sum test, and the Fisher exact test. Overall associations of primary and secondary endpoints with type of bacterial overgrowth were assessed by analysis of variance F-test, Kruskal-Wallis test, and the Fisher exact tests. Associations of risk factors with type of overgrowth were explored using multinomial logistic regression.

Results: Among 76 patients, 37 had SIBO (68% coliform, 33% UAT) and 39 did not. Conditions (P=0.02) and surgery (P<0.01) associated with decreased gastric acid were associated with SIBO. In multinomial logistic regression, conditions of decreased acid was associated with UAT SIBO [odds ratio (OR), 5.8; 95% confidence interval, 1.4-33.3]. Surgery causing decreased acid was associated with UAT [OR, 9.5 (1.4-106)] and coliform SIBO [OR, 8.4 (1.6-86.4)]. Three patients with discontinuous small bowel had coliform SIBO [OR, 17.4 (1.2-2515)]. There were no differences in complications, overall symptoms, quality of life, or psychological traits.

Conclusions: Conditions or surgeries associated with decreased gastric acid are associated with SIBO diagnosis by culture.
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http://dx.doi.org/10.1097/MCG.0000000000001150DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7909722PMC
February 2020
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