Publications by authors named "Carlo Catassi"

110 Publications

Navigating celiac disease and the gluten-free diet in China.

Nutr Health 2021 Apr 11:260106021990254. Epub 2021 Apr 11.

Celiac Disease Center, 21611Columbia University Irving Medical Center, USA.

Background: Little is known about celiac disease (CeD) diagnosis and management in China.

Aim: This pilot aimed to be the first study to describe, quantitatively and qualitatively, how individuals living in China navigate CeD and the gluten-free diet (GFD).

Methods: Participants were 13 adults and four parents of children with reported CeD, recruited from 11 mainland China cities via an online GFD support group. CeD-specific quality of life (CD-QOL and CD-PQOL) and diet adherence (CDAT) were assessed. In-depth interviews addressed experiences with CeD and the GFD.

Results: Six of 17 participants reported biopsy- or serology-confirmed CeD. The mean (SD) adult CDAT score was 15.2 (3.6), > 13 indicating inadequate GFD adherence. The mean adult CD-QOL score was 62.1 (24.1) out of 100, in the "medium" to "good" range. Results were similar in children. Major interview themes included: (1) a challenging journey to obtain diagnosis; (2) social and structural barriers to maintaining the GFD; and (3) reliance on self in management of CeD.

Conclusion: Obtaining a diagnosis, maintaining a GFD, and living with CeD can be extremely challenging in mainland China. Results suggest an urgent need for CeD-specific education and Asian-adapted GFD guidance for both healthcare practitioners and patients.
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http://dx.doi.org/10.1177/0260106021990254DOI Listing
April 2021

Quantification of Accidental Gluten Contamination in the Diet of Children with Treated Celiac Disease.

Nutrients 2021 Jan 9;13(1). Epub 2021 Jan 9.

Division of Pediatrics, DISCO Department, Polytechnic University of Marche, 60123 Ancona, Italy.

A strict gluten-free diet is extremely difficult to maintain. Protracted ingestion of gluten traces (>10 mg/day) is sufficient to cause significant damage in the architecture of the small intestinal mucosa in patients on treatment for celiac disease. The aim of this study was to directly measure the level of contaminating gluten in the daily diet of celiac children following a gluten-free diet. From April 2019 to December 2019, celiac disease children (2-18 years old) on a gluten-free diet for ≥6 months were offered to participate in this prospective-observational study. Patients and their caregivers were invited to provide a representative portion (about 10 g) of all meals consumed during a 24-h period. Participants were requested to weigh all ingested food and report items in a 24-h food diary. The gluten content was quantified by the R5 sandwich enzyme-linked immunosorbent assay method. Sixty-nine children completed the protocol. Overall, 12/448 (2.7%) food samples contained detectable amounts of gluten; of them, 11 contained 5-20 ppm and 1 >20 ppm. The 12 contaminated food samples belonged to 5/69 enrolled patients. In these 5 children, the daily gluten intake was well below the safety threshold of 10 mg/day. The present findings suggest that in a country characterized by high celiac disease awareness, the daily unintended exposure to gluten of treated celiac children on regular follow-up is very low; reassuringly, the presence of gluten traces did not lead to exceed the tolerable threshold of 10 mg/day of gluten intake in the gluten-free diet.
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http://dx.doi.org/10.3390/nu13010190DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7827942PMC
January 2021

Prevalence of COVID-19 in Italian Children With Celiac Disease: A Cross-Sectional Study.

Clin Gastroenterol Hepatol 2021 May 3;19(5):1075. Epub 2020 Dec 3.

Center for Celiac Research and Treatment, Massachusetts General Hospital for Children, Boston, Massachusetts.

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http://dx.doi.org/10.1016/j.cgh.2020.11.035DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7713539PMC
May 2021

Adherence to the Gluten-Free Diet during the Lockdown for COVID-19 Pandemic: A Web-Based Survey of Italian Subjects with Celiac Disease.

Nutrients 2020 Nov 12;12(11). Epub 2020 Nov 12.

Department of Pediatrics, Marche Polytechnic University, 60020 Ancona, Italy.

We aimed to assess the perceived impact of the lockdown, imposed to control the spreading of COVID-19, on the adherence of Italian celiac disease (CD) subjects to the gluten-free diet by a web-based survey. A total of 1983 responses were analyzed, 1614 (81.4%) by CD adults and 369 (18.6%) by parents/caregivers of CD children/adolescents. The compliance with the GFD was unchanged for 69% of the adults and 70% of the children, and improved for 29% of both. The factors increasing the probability to report stricter compliance were the presence of CD symptoms in the last year before the lockdown (odds ratio (OR) 1.98, 95% confidence interval (CI) 1.46-2.26), a partial usual adherence to gluten-free diet (GFD) (OR 1.91, 95% CI 1.2-3.06), and having tried recipes with naturally gluten-free ingredients more than usual (OR 1.58, 95% CI 1.28-1.96) for adults; the presence of CD symptoms in the last year (OR 2.05, 95% CI 1.21-3.47), still positive CD antibodies (OR 1.89, 95% CI 1.14-3.13), and other family members with CD (OR 2.24, 95% CI 1.3-3.85) for children/adolescents. Therefore, the lockdown led to a reported improved adherence to the GFD in one-third of the respondents, in particular in those with previous worse disease control, offering the opportunity to avoid sources of contamination/transgression and increase the use of naturally gluten-free products.
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http://dx.doi.org/10.3390/nu12113467DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7698218PMC
November 2020

Early biochemical effects of velmanase alfa in a 7-month-old infant with alpha-mannosidosis.

JIMD Rep 2020 Sep 10;55(1):15-21. Epub 2020 Jul 10.

Department of Clinical Sciences, Division of Pediatrics Polytechnic University of Marche, Ospedali Riuniti, Presidio Salesi Ancona Italy.

Alpha mannosidosis is an ultrarare pathology with variable phenotypic manifestations, characterized by the deficiency of lysosomal alpha mannosidase which causes accumulation of neutral oligosaccharides. Until recently, the hematopoietic stem cell transplantation was the only clinical feasible therapeutic option. Only in 2018, the European Medicines Agency's committee approved the recombinant enzyme velmanase alfa for long-term treatment of non-neurological manifestations in mild and moderate forms of alpha-mannosidosis. In this study, the very early biochemical effects of enzyme replacement therapy in in a 7-month-old patient with alpha-mannosidosis were described. Velmanase alpha was administered as supporting therapy awaiting for hematopoietic stem cell transplantation, the treatment chosen for the patient because of the early onset form. The results showed that the enzyme replacement therapy was able to reduce the content of three different mannosyl-oligosaccharides monitored by tandem mass spectrometry after 2 months of treatment. In particular, the mean relative changes from baseline values were -67% in urine and -53% in serum at the latest observation. The study also showed that the enzymatic activity detected in serum 1 week after the first infusion was four times higher than the normal values and constant in the following points of observation. These findings led us to assume that velmanase alfa might be biologically active in this young patient.
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http://dx.doi.org/10.1002/jmd2.12144DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7463052PMC
September 2020

Lower Level of Plasma 25-Hydroxyvitamin D in Children at Diagnosis of Celiac Disease Compared with Healthy Subjects: A Case-Control Study.

J Pediatr 2021 01 2;228:132-137.e1. Epub 2020 Sep 2.

Department of Pediatrics, Marche Polytechnic University, Ancona, Italy; Center for Celiac Research, Mass General Hospital for Children, Boston, MA.

Objective: To evaluate the vitamin D status of children with a new diagnosis of celiac disease compared with healthy controls.

Study Design: This was a case-control study. Cases were consecutive children with newly diagnosed celiac disease. Controls were healthy children matched for age, sex, ethnicity, and month of blood testing. Plasma 25-hydroxyvitamin D (25-OHD) was measured as the index of vitamin D nutritional status. The Student t test was used for comparisons. Differences in frequencies were evaluated with the χ test. Associations between variables were estimated by calculating Pearson correlation coefficients.

Results: There were 131 children with celiac disease enrolled (62% females; mean age 8.1 ± 1.1 years). The control group included 131 healthy children (62% females; mean age 8.2 ± 1.2). All were of European origin. Plasma 25-OHD levels were significantly lower in patients than in controls (25.3 ± 8.0 and 31.6 ± 13.7 ng/mL; P < .0001). The percentage of children with vitamin D deficiency (<20 ng/mL) was significantly higher in children with celiac diseaseas compared with controls (31% vs 12%; P < .0001). The concentration of 25-OHD was significantly lower in patients than in controls during summer (P < .01) and autumn (P < .0001).

Conclusions: In this case-control study, at diagnosis, children with celiac disease showed lower levels of plasma 25-OHD compared with healthy subjects. Vitamin D status should be checked at diagnosis of celiac disease, particularly during summer and fall months.
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http://dx.doi.org/10.1016/j.jpeds.2020.08.089DOI Listing
January 2021

A negative fallout of COVID-19 lockdown in Italy: Life-threatening delay in the diagnosis of celiac disease.

Dig Liver Dis 2020 10 16;52(10):1092-1093. Epub 2020 May 16.

Department of Pediatrics, Polytechnic University of Marche, Ancona, Italy; Center for Celiac Research and Treatment, Division of Pediatric Gastroenterology and Nutrition, MassGeneral Hospital for Children, Boston, MA, USA. Electronic address:

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http://dx.doi.org/10.1016/j.dld.2020.05.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7229920PMC
October 2020

Recent Progress and Recommendations on Celiac Disease From the Working Group on Prolamin Analysis and Toxicity.

Front Nutr 2020 17;7:29. Epub 2020 Mar 17.

biotask AG, Esslingen, Germany.

Celiac disease (CD) affects a growing number of individuals worldwide. To elucidate the causes for this increase, future multidisciplinary collaboration is key to understanding the interactions between immunoreactive components in gluten-containing cereals and the human gastrointestinal tract and immune system and to devise strategies for CD prevention and treatment beyond the gluten-free diet. During the last meetings, the Working Group on Prolamin Analysis and Toxicity (Prolamin Working Group, PWG) discussed recent progress in the field together with key stakeholders from celiac disease societies, academia, industry and regulatory bodies. Based on the current state of knowledge, this perspective from the PWG members provides recommendations regarding clinical, analytical and legal aspects of CD. The selected key topics that require future multidisciplinary collaborative efforts in the clinical field are to collect robust data on the increasing prevalence of CD, to evaluate what is special about gluten-specific T cells, to study their kinetics and transcriptomics and to put some attention to the identification of the environmental agents that facilitate the breaking of tolerance to gluten. In the field of gluten analysis, the key topics are the precise assessment of gluten immunoreactive components in wheat, rye and barley to understand how these are affected by genetic and environmental factors, the comparison of different methods for compliance monitoring of gluten-free products and the development of improved reference materials for gluten analysis.
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http://dx.doi.org/10.3389/fnut.2020.00029DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7090026PMC
March 2020

Nutritional Status, Dietary Intake, and Adherence to the Mediterranean Diet of Children with Celiac Disease on a Gluten-Free Diet: A Case-Control Prospective Study.

Nutrients 2020 Jan 4;12(1). Epub 2020 Jan 4.

Department of Pediatrics, Marche Polytechnic University, 60123 Ancona, Italy.

The only effective treatment for celiac disease (CD) is a life-long strict gluten-free diet (GFD). Nutritional adequacy of the GFD has remained controversial and a matter of debate for a long time. No large case-control studies on children regarding the nutritional adequacy of the GFD has been performed. In this study, children diagnosed with CD on a GFD for ≥ 2 years were recruited. Controls were age and gender-matched healthy children not affected with CD. In both groups, anthropometric measurements and energy expenditure information were collected. Dietary assessment was performed by a 3-day food diary. Adherence to the Mediterranean diet was estimated by the KIDMED index. Overall, 120 children with CD and 100 healthy children were enrolled. No differences were found between CD children and controls in anthropometric measurements and energy expenditure. In the CD group, the daily intake of fats was significantly higher while the consumption of fiber was lower in comparison with the control group. The median KIDMED index was 6.5 in CD children and 6.8 in healthy controls. The diet of children with CD in this study was nutritionally less balanced than controls, with a higher intake of fat and a lower intake of fiber, highlighting the need for dietary counseling.
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http://dx.doi.org/10.3390/nu12010143DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7019969PMC
January 2020

Misuse of serological screening tests for celiac disease in children: A prospective study in Italy.

Dig Liver Dis 2019 11 3;51(11):1547-1550. Epub 2019 Aug 3.

Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy; Center for Celiac Research and Treatment, Mass General Hospital for Children, Boston, MA 02114, USA. Electronic address:

Background: Despite a well-established diagnostic algorithm for celiac disease, it remains unclear whether prescriptions for celiac serological tests comply with the current pediatric guidelines.

Aim: To analyze the appropriateness of test prescription in children investigated for celiac disease in Italy, compared to the current European pediatric guidelines.

Methods: All children who had performed a first evaluation for celiac disease were prospectively enrolled. Prescribed tests and related indications for testing were recorded, and compared to the European pediatric guidelines.

Results: Overall, 202 children were enrolled (females 59%, mean age 7.1 years ±4.1) in two centers. The reasons for celiac disease testing were typical, atypical symptoms or celiac disease-associated conditions in 46.5%, 49%, and 4.5% of cases, respectively. First-line tests were IgA and IgG anti-transglutaminase antibodies in 88.1% and 29.7% of children, IgA and IgG anti-deamidated gliadin peptide antibodies in 43% and 47%, IgA and IgG anti native gliadin in 15.8%, IgA anti-endomysium antibodies in 44.5%, HLA predisposing genes in 10% of patients. Test redundancy was very common, and the current diagnostic guidelines were correctly followed only in 23/202 patients (11.4%).

Conclusions: Diagnostic European guidelines for celiac disease screening are often disregarded in Italy. Intervention to implement adherence to these guidelines is needed, with the aim of improving resource utilization, and quality of patient care.
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http://dx.doi.org/10.1016/j.dld.2019.06.016DOI Listing
November 2019

Celiac disease: a comprehensive current review.

BMC Med 2019 07 23;17(1):142. Epub 2019 Jul 23.

Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, MA, 02114, USA.

Background: Celiac disease remains a challenging condition because of a steady increase in knowledge tackling its pathophysiology, diagnosis, management, and possible therapeutic options.

Main Body: A major milestone in the history of celiac disease was the identification of tissue transglutaminase as the autoantigen, thereby confirming the autoimmune nature of this disorder. A genetic background (HLA-DQ2/DQ8 positivity and non-HLA genes) is a mandatory determinant of the development of the disease, which occurs with the contribution of environmental factors (e.g., viral infections and dysbiosis of gut microbiota). Its prevalence in the general population is of approximately 1%, with female predominance. The disease can occur at any age, with a variety of symptoms/manifestations. This multifaceted clinical presentation leads to several phenotypes, i.e., gastrointestinal, extraintestinal, subclinical, potential, seronegative, non-responsive, and refractory. Although small intestinal biopsy remains the diagnostic 'gold standard', highly sensitive and specific serological tests, such as tissue transglutaminase, endomysial and deamidated gliadin peptide antibodies, have become gradually more important in the diagnostic work-up of celiac disease. Currently, the only treatment for celiac disease is a life-long, strict gluten-free diet leading to improvement in quality of life, ameliorating symptoms, and preventing the occurrence of refractory celiac disease, ulcerative jejunoileitis, and small intestinal adenocarcinoma and lymphoma.

Conclusions: The present review is timely and provides a thorough appraisal of various aspects characterizing celiac disease. Remaining challenges include obtaining a better understanding of still-unclear phenotypes such as slow-responsive, potential (minimal lesions) and seronegative celiac disease. The identification of alternative or complementary treatments to the gluten-free diet brings hope for patients unavoidably burdened by diet restrictions.
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http://dx.doi.org/10.1186/s12916-019-1380-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647104PMC
July 2019

Increased Prevalence of Celiac Disease in School-age Children in Italy.

Clin Gastroenterol Hepatol 2020 03 17;18(3):596-603. Epub 2019 Jun 17.

Department of Pediatrics, Marche Polytechnic University, Ancona, Italy; Mucosal Immunology and Biology Research Center, Division of Pediatric Gastroenterology and Nutrition, Massachusetts General Hospital, Boston, Massachusetts. Electronic address:

Background & Aims: Celiac disease is one of the most common diseases worldwide, with an apparent trend of increasing prevalence. We investigated the prevalence of celiac disease in children in Italy in 2015-2016 and compared that with data from 25 years ago.

Methods: We screened 4570 children (5-11 years old, 80.1% of the eligible population) from metropolitan areas of Ancona and Verona for HLA genes associated with increased risk of celiac disease, and for total serum levels of IgA and IgA class anti-tissue transglutaminase in HLA positives. Diagnoses of celiac disease were confirmed by detection of anti-endomysial antibody and analysis of intestinal biopsies. The prevalence of celiac autoimmunity and celiac disease were calculated and compared with values from the same geographical area during the years 1993-1995, after adjustment for the different diagnostic algorithm.

Results: We identified 1960 children with celiac disease-associated haplotypes (43% of children screened; 95% CI, 40.8%-45.2%). The prevalence of celiac disease autoimmunity in the HLA-positive subjects was 96/1706 (5.62%; 95% CI, 4.53%-6.71%) and 54 of these children satisfied the diagnostic criteria for celiac disease. In the eligible population there were other 23 known cases of celiac disease. The overall estimated prevalence of celiac disease was 1.58% (95% CI, 1.26%-1.90%); this value is significantly higher than the 1993-1995 adjusted prevalence (0.88%; 95% CI, 0.74%-1.02%).

Conclusions: We found the prevalence of celiac disease in children in Italy to be greater than 1.5%; this value has increased significantly over the past 25 years. Studies are needed to determine the causes of this large increase.
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http://dx.doi.org/10.1016/j.cgh.2019.06.013DOI Listing
March 2020

Celiac Disease Prevalence is Increased in Primary Sjögren's Syndrome and Diffuse Systemic Sclerosis: Lessons from a Large Multi-Center Study.

J Clin Med 2019 Apr 19;8(4). Epub 2019 Apr 19.

Rheumatology Unit, Department of Medicine, University of Perugia, 06128 Perugia, Italy .

Association of celiac disease (CD) with systemic autoimmune diseases (ADs) remains controversial. Awareness of CD in these patients is important to prevent complications, including lymphoproliferative disorders. We evaluated previously diagnosed CD prevalence in systemic lupus erythematosus (SLE), primary Sjögren's syndrome (pSS) and systemic sclerosis (SSc) patients in comparison to 14,298 matched controls. All patients were screened for subclinical CD. Data from 1458 unselected consecutive SLE (580), pSS (354) and SSc (524) patients were collected. Previously biopsy-proven CD diagnosis and both CD- and AD-specific features were registered. All patients without previous CD were tested for IgA transglutaminase (TG). Anti-endomysium were tested in positive/borderline IgA TG. Duodenal biopsy was performed in IgA TG/endomysium+ to confirm CD. CD prevalence in AD was compared to that observed in 14,298 unselected sex- and age-matched adults who acted as controls. CD was more prevalent in pSS vs controls (6.78% vs 0.64%, < 0.0001). A trend towards higher prevalence was observed in SLE (1.38%, = 0.058) and SSc (1.34%, = 0.096). Higher CD prevalence was observed in diffuse cutaneous SSc (4.5%, ≤ 0.002 vs controls). Subclinical CD was found in two SLE patients and one pSS patient. CD diagnosis usually preceded that of AD. Primary SS and SSc-CD patients were younger at AD diagnosis in comparison to non-celiac patients. Autoimmune thyroiditis was associated with pSS and CD. CD prevalence is clearly increased in pSS and diffuse SSc in comparison to the general population. The association of CD with diffuse but not limited SSc may suggest different immunopathogenic mechanisms characterizing the two subsets. CD screening may be considered in pSS and diffuse SSc in young patients, particularly at the time of diagnosis.
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http://dx.doi.org/10.3390/jcm8040540DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6517955PMC
April 2019

Long-Term Outcome of Potential Celiac Disease in Genetically at-Risk Children: The Prospective CELIPREV Cohort Study.

J Clin Med 2019 Feb 5;8(2). Epub 2019 Feb 5.

Department of Pediatrics, Marche Polytechnic University, 60123 Ancona, Italy.

Background: The long-term outcome of potential celiac disease (CD) is still a debated issue. We aimed to evaluate the progression of potential CD versus overt CD after 10-years of follow-up in a cohort of children genetically predisposed to CD.

Methods: The CELIPREV study is prospectively following from birth 553 children with CD-predisposing HLA genes. Children with a diagnosis of potential CD continued to receive a normal diet and repeated the serological screening for CD every year. An intestinal biopsy was taken in presence of persistent positive serology.

Results: Overall, 26 (4.7%) children received a diagnosis of potential CD (50% females, median age 24 months). All children were symptom-free. Twenty-three children continued a gluten-containing diet; at 10 years from the first biopsy, three children developed overt CD (13%), 19 (83%) became antibodies negative at 1 year from the first biopsy and remained negative up to 10 years of follow-up and one subject (4%) had fluctuating antibody course with transiently negative values and persistently negative biopsy.

Conclusions: In children genetically predisposed to CD with a diagnosis of potential CD the risk of progression to overt CD while on a gluten-containing diet is very low in the long-term.
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http://dx.doi.org/10.3390/jcm8020186DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6406363PMC
February 2019

Celiac Disease in Asia.

Gastroenterol Clin North Am 2019 03 13;48(1):101-113. Epub 2018 Dec 13.

Department of Pediatrics, Center for Celiac Research, Università Politecnica delle Marche, Piazzale Martelli Raffaele, 8, Ancona, Ancona 60121, Italy; Division of Pediatric Gastroenterology, Massachussets General Hospital, Boston, MA 33131, USA.

Celiac disease, once thought to be very uncommon in Asia, is now emerging in many Asian countries. Although the absolute number of patients with celiac disease at present is not very high, this number is expected to increase markedly over the next few years/decades owing to increasing awareness. It is now that the medical community across the Asia should define the extent of the problem and prepare to handle the impending epidemic of celiac disease in Asia.
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http://dx.doi.org/10.1016/j.gtc.2018.09.007DOI Listing
March 2019

Pediatric Celiac Disease in Central and East Asia: Current Knowledge and Prevalence.

Medicina (Kaunas) 2019 Jan 12;55(1). Epub 2019 Jan 12.

Department of Pediatrics, Universita' Politecnica delle Marche, 60121 Ancona, Italy.

The current prevalence of pediatric Celiac Disease (CD) is estimated to be around 1% in the general population, worldwide. However, according to the geographic area, a great variability of CD prevalence has been described. Whereas a number of studies are available from Europe, North and South America, Australia, South-West Asia, and North Africa, the knowledge and awareness of CD in large parts of the remaining world areas is definitively poor. In several countries of Central and East Asia, the consumption of wheat is consistent and/or has significantly increased in recent decades, and CD is supposed to be underdiagnosed in children. In this mini-review, we aimed to summarize the current knowledge about the prevalence of pediatric CD in Central and East Asia, paying attention to the HLA-DQ immunogenetic background as well. Indeed, CD is likely not to be as uncommon as previously or currently thought in countries like Russia, Kazakhstan, and China, in addition to India, where pediatric CD has been clearly showed to be quite prevalent. Therefore, there is an urgent need for population-based studies on the prevalence of CD in those countries, especially in children, in order to increase the awareness of this disease and to improve the diagnostic strategy in these areas.
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http://dx.doi.org/10.3390/medicina55010011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6359221PMC
January 2019

Validation of a novel single-drop rapid human leukocyte antigen-DQ2/-DQ8 typing method to identify subjects susceptible to celiac disease.

JGH Open 2018 Dec 1;2(6):311-316. Epub 2018 Nov 1.

Department of Gastroenterology and Human Nutrition All India Institute of Medical Sciences New Delhi India.

Background And Aim: Human leukocyte antigen (HLA)-DQ2 and/or -DQ8 is an essential risk factor for celiac disease (CD). About 90-95% of patients with CD carry HLA-DQ2/-DQ8 alleles, and HLA-DQ typing is considered an additional diagnostic test. Conventional polymerase chain reaction (PCR)-based HLA-DQ typing methods are expensive, complex, and a time-consuming process. We assessed the efficacy of a novel HLA-DQ typing method, "Celiac Gene Screen," for the detection of CD-associated HLA haplotypes.

Methods: To assess the diagnostic performance of the Celiac Gene Screen test, 100 ethylenediaminetetraacetic acid (EDTA) blood samples, already characterized by the conventional HLA-DQ typing method, that is, PCR sequence-specific oligonucleotide probes (PCR-SSOP), a concordance between both the methods were explored. For validity, a further 300 EDTA blood samples with unknown HLA-DQ status were genotyped using the Celiac Gene Screen test, including 141 samples from CD, 56 first-degree relatives (FDRs) of CD and 103 samples from controls.

Results: Of the 100 samples with known status of HLA-DQ alleles, 79 samples were HLA-DQ2 and/or -DQ8 positive, and 21 samples were HLA-DQ2 and/or -DQ8 negative by conventional PCR. These 100 samples were re-typed using the Celiac Gene screen kit; all 79 positives were typed positive, and 21 negatives were typed negative for HLA-DQ alleles. Among 300 samples with unknown HLA-DQ status, 118 of 141 (84%) patients with CD, 48 of 56 (86%) FDRs of CD, and 52 of 103 (50%) controls typed positive for HLA-DQ alleles.

Conclusions: The Celiac Gene Screen HLA-DQ typing method showed excellent concordance with the conventional HLA-DQ typing method and could be a cost-reducing and effective method for CD-associated HLA screening.
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http://dx.doi.org/10.1002/jgh3.12090DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6308057PMC
December 2018

The puzzling relationship between human leukocyte antigen HLA genes and celiac disease.

Saudi J Gastroenterol 2018 Sep-Oct;24(5):257-258

Department of Pediatrics, Marche Polytechnic University, Ancona, Italy.

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http://dx.doi.org/10.4103/sjg.SJG_388_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6152000PMC
October 2018

Contribution of Oral Hygiene and Cosmetics on Contamination of Gluten-free Diet: Do Celiac Customers Need to Worry About?

J Pediatr Gastroenterol Nutr 2019 01;68(1):26-29

Department of Pediatrics, Marche Polytechnic University, Ancona, Italy.

Objectives: The only available treatment for celiac disease (CD) is the gluten-free diet. It is unclear whether the presence of gluten in oral hygiene products and cosmetics that are applied on the mouth is a reason of concern for CD patients. The aim of this study was to test the level of gluten contamination in oral hygiene and cosmetic products available in the Italian market.

Methods: A total of 66 products (toothpastes = 37; dental tablets = 2; mouthwashes = 5; lip-balms = 10; lipsticks = 12) labelled gluten-free or with unknown gluten content were randomly collected from different supermarkets and pharmacies. The gluten quantification was determined by the R5 ELISA method approved by EU regulations.

Results: Out of 66 oral hygiene and cosmetics, 62 products (94%) were found to be gluten-free (gluten level <20 ppm), while 4 (6%) (toothpastes = 3; lipsticks = 1) showed a gluten level >20 ppm (toothpastes: 20.7, 31.4, and 35 ppm; lipstick: 27.4 ppm). None of the selected products had ingredient derived from wheat, barley, or rye.

Conclusions: Gluten contamination is currently not an issue in a wide array of cosmetic and oral hygiene products that are commonly in the market.
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http://dx.doi.org/10.1097/MPG.0000000000002129DOI Listing
January 2019

False positive screen test for mucopolysaccharidoses in healthy female newborns.

Clin Chim Acta 2018 Nov 12;486:221-223. Epub 2018 Aug 12.

Department of Clinical Sciences, Division of Pediatrics, Polytechnic University of Marche, Ospedali Riuniti, Presidio Salesi, Ancona, Italy. Electronic address:

Background: In total, 930 urine samples obtained on 2nd and 3rd day from birth have been analyzed for the early diagnosis of Mucopolysaccharidoses.

Methods: Dimethylmethylene blue (DMB) assay and one-dimensional electrophoresis were performed in all urine samples. Agarose gel electrophoresis, before and after treatment with chondroitinase ABC and heparinases, was used for a comprehensive characterization.

Results: Out of 930 urine samples 7 showed anomalous electrophoretic pattern; 5 of them had high GAG levels by DMB test. Atypical samples (n = 7) were analyzed by agarose gel electrophoresis. After enzymatic digestion, some slow bands were still visible. A second urine sample of the above 7 newborns was analyzed at the age of 1 month, demonstrating both a normal pattern and normal GAG levels. Additional urine and vaginal mucus samples from 10 term neonates with vaginal bleeding showed the same electrophoretic pattern observed in the 7 false positive samples.

Conclusions: The altered electrophoretic pattern may be due to the presence of glycoproteins and not to specific GAGs, due to high levels of maternal hormones exposure during pregnancy. To our knowledge, this is the first time maternal estrogen hormones are proposed as a likely cause of false-positive urinary glycosaminoglycan screen test in healthy newborns.
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http://dx.doi.org/10.1016/j.cca.2018.08.016DOI Listing
November 2018

Comparison of Diagnostic Performance of the IgA Anti-tTG Test vs IgA Anti-Native Gliadin Antibodies Test in Detection of Celiac Disease in the General Population.

Clin Gastroenterol Hepatol 2018 12 31;16(12):1997-1998. Epub 2018 Mar 31.

Celiac Disease Research Laboratory, Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy; Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy.

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http://dx.doi.org/10.1016/j.cgh.2018.03.028DOI Listing
December 2018

Breast milk oligosaccharides: effects of 2'-fucosyllactose and 6'-sialyllactose on the adhesion of and to Caco-2 cells.

J Matern Fetal Neonatal Med 2019 Sep 21;32(17):2950-2952. Epub 2018 Mar 21.

b Department of Clinical Sciences, Pediatric Division , Polytechnic University of Marche, Ospedali Riuniti , Ancona , Italy.

It is well known that human milk oligosaccharides play an important role as prebiotics, anti-inflammatory, and anti-infective agents. In the last few years, several studies have been performed using specific oligosaccharides, such as 2'-fucosyllactose and 6'-sialylactose, to evaluate their biological functions. The aim of the present study is to evaluate the anti-adhesive effect of the above oligosaccharides on and . Adhesion experiments were performed in the presence of 2'-fucosyllactose and 6'-sialyllactose as potential inhibitors of and adhesion to Caco-2 cells. The oligosaccharides were used at different concentrations and the adhesion experiments were performed in triplicate and repeated at least three times. A significant reduction of adhesion was observed in the presence of 2'-fucosyllactose and 6'-sialyllactose at the human milk concentration. On the contrary, no positive effects were observed in both oligosaccharides on . Our results suggest that the supplementation in infant formulas of 2'-fucosyllactose and 6'-sialyllactose, actually commercially available and absent in cow milk, could play positive effects in artificially fed infants.
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http://dx.doi.org/10.1080/14767058.2018.1450864DOI Listing
September 2019

Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis.

Clin Gastroenterol Hepatol 2018 06 16;16(6):823-836.e2. Epub 2018 Mar 16.

Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address:

Background & Aims: Celiac disease is a major public health problem worldwide. Although initially it was reported from countries with predominant Caucasian populations, it now has been reported from other parts of the world. The exact global prevalence of celiac disease is not known. We conducted a systematic review and meta-analysis to estimate the global prevalence of celiac disease.

Methods: We searched Medline, PubMed, and EMBASE for the keywords celiac disease, celiac, celiac disease, tissue transglutaminase antibody, anti-endomysium antibody, endomysial antibody, and prevalence for studies published from January 1991 through March 2016. Each article was cross-referenced with the words Asia, Europe, Africa, South America, North America, and Australia. The diagnosis of celiac disease was based on European Society of Pediatric Gastroenterology, Hepatology, and Nutrition guidelines. Of 3843 articles, 96 articles were included in the final analysis.

Results: The pooled global prevalence of celiac disease was 1.4% (95% confidence interval, 1.1%-1.7%) in 275,818 individuals, based on positive results from tests for anti-tissue transglutaminase and/or anti-endomysial antibodies (called seroprevalence). The pooled global prevalence of biopsy-confirmed celiac disease was 0.7% (95% confidence interval, 0.5%-0.9%) in 138,792 individuals. The prevalence values for celiac disease were 0.4% in South America, 0.5% in Africa and North America, 0.6% in Asia, and 0.8% in Europe and Oceania; the prevalence was higher in female vs male individuals (0.6% vs 0.4%; P < .001). The prevalence of celiac disease was significantly greater in children than adults (0.9% vs 0.5%; P < .001).

Conclusions: In a systematic review and meta-analysis, we found celiac disease to be reported worldwide. The prevalence of celiac disease based on serologic test results is 1.4% and based on biopsy results is 0.7%. The prevalence of celiac disease varies with sex, age, and location. There is a need for population-based prevalence studies in many countries.
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http://dx.doi.org/10.1016/j.cgh.2017.06.037DOI Listing
June 2018

Assessment of Mycotoxin Exposure in Breastfeeding Mothers with Celiac Disease.

Nutrients 2018 Mar 10;10(3). Epub 2018 Mar 10.

Department of Pediatrics, Università Politecnica delle Marche, 60123 Ancona, Italy.

Objective: To assess the risk of mycotoxin exposure (aflatoxin M1, ochratoxin A, and zearalenone) in celiac disease (CD) breastfeeding mothers and healthy control mothers, as well as in their offspring, by quantifying these contaminants in breast milk.

Study Design: Thirty-five breastfeeding women with CD on a gluten-free diet and 30 healthy breastfeeding controls were recruited. Milk sampling was performed three times per day for three consecutive days. Mycotoxin content was investigated by an analytical method using immunoaffinity column clean-up and high-performance liquid chromatography (HPLC) with fluorometric detection.

Results: Aflatoxin M1 (AFM1) was detected in 37% of CD group samples (mean ± SD = 0.012 ± 0.011 ng/mL; range = 0.003-0.340 ng/mL). The control group showed lower mean AFM1 concentration levels in 24% of the analyzed samples (0.009 ± 0.007 ng/mL; range = 0.003-0.067 ng/mL, ANOVA on ranks, -value < 0.01). Ochratoxin A and zearalenone did not differ in both groups.

Conclusion: Breast milk AFM1 contamination for both groups is lower than the European safety threshold. However, the estimated exposures of infants from CD mothers and control mothers was much higher (≃15 times and ≃11 times, respectively) than the threshold set by the joint FAO/WHO Expert Committee on Food Additives (JECFA). Since incongruities exist between JECFA and the European Union standard, a novel regulatory review of the available data on this topic is desirable. Protecting babies from a neglected risk of high AFM1 exposure requires prompt regulatory and food-control policies.
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http://dx.doi.org/10.3390/nu10030336DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5872754PMC
March 2018

Safety of Oats in Children with Celiac Disease: A Double-Blind, Randomized, Placebo-Controlled Trial.

J Pediatr 2018 03;194:116-122.e2

Department of Pediatrics, Marche Polytechnic University, Ancona, Italy.

Objective: To evaluate the long-term validity and safety of pure oats in the treatment of children with celiac disease.

Study Design: This noninferiority clinical trial used a double-blind, placebo-controlled, crossover design extended over 15 months. Three hundred six children with a biopsy-proven diagnosis of celiac disease on a gluten-free diet for ≥2 years were randomly assigned to eat specifically prepared gluten-free food containing an age-dependent amount (15-40 g) of either placebo or purified nonreactive varieties of oats for 2 consecutive 6-month periods separated by washout standard gluten-free diet for 3 months. Clinical (body mass index, Gastrointestinal Symptoms Rating Scale score), serologic (IgA antitransglutaminase antibodies, and IgA anti-avenin antibodies), and intestinal permeability data were measured at baseline, and after 6, 9, and 15 months. Direct treatment effect was evaluated by a nonparametric approach using medians (95% CI) as summary statistic.

Results: After the exclusion of 129 patients who dropped out, the cohort included 177 children (79 in the oats-placebo and 98 in the placebo-oats group; median, 0.004; 95% CI, -0.0002 to 0.0089). Direct treatment effect was not statistically significant for clinical, serologic, and intestinal permeability variables (body mass index: median, -0.5; 95% CI, -0.12 to 0.00; Gastrointestinal Symptoms Rating Scale score: median, 0; 95% CI, -2.5 to 0.00; IgA antitransglutaminase antibodies: median, -0.02; 95% CI, -0.25 to 0.23; IgA anti-avenin antibodies: median, -0.0002; 95% CI, -0.0007 to 0.0003; intestinal permeability test: median, 0.004; 95% CI, -0.0002 to 0.0089).

Conclusions: Pure nonreactive oat products are a safe dietary choice in the treatment of children with celiac disease.

Trial Registration: ClinicalTrials.gov: NCT00808301.
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http://dx.doi.org/10.1016/j.jpeds.2017.10.062DOI Listing
March 2018

The Overlapping Area of Non-Celiac Gluten Sensitivity (NCGS) and Wheat-Sensitive Irritable Bowel Syndrome (IBS): An Update.

Nutrients 2017 Nov 21;9(11). Epub 2017 Nov 21.

Academic Unit of Gastroenterology, Department of Infection, Immunity & Cardiovascular Disease, University of Sheffield, Sheffield S10 2TN, UK.

Gluten-related disorders have recently been reclassified with an emerging scientific literature supporting the concept of non-celiac gluten sensitivity (NCGS). New research has specifically addressed prevalence, immune mechanisms, the recognition of non-immunoglobulin E (non-IgE) wheat allergy and overlap of NCGS with irritable bowel syndrome (IBS)-type symptoms. This review article will provide clinicians with an update that directly impacts on the management of a subgroup of their IBS patients whose symptoms are triggered by wheat ingestion.
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http://dx.doi.org/10.3390/nu9111268DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707740PMC
November 2017

Pediatric Chronic Intestinal Failure in Italy: Report from the 2016 Survey on Behalf of Italian Society for Gastroenterology, Hepatology and Nutrition (SIGENP).

Nutrients 2017 Nov 5;9(11). Epub 2017 Nov 5.

Pediatric Surgery Unit, Women's and Children's Health Department, University of Padua, 35122 Padua, Italy.

Background: Intestinal failure (IF) is the reduction in functioning gut mass below the minimal level necessary for adequate digestion and absorption of nutrients and fluids for weight maintenance in adults or for growth in children. There is a paucity of epidemiologic data on pediatric IF. The purpose of this study was to determine the prevalence, incidence, regional distribution and underlying diagnosis of pediatric chronic IF (CIF) requiring home parenteral nutrition (HPN) in Italy.

Methods: Local investigators were selected in 19 Italian centers either of reference for pediatric HPN or having pediatric gastroenterologists or surgeons on staff and already collaborating with the Italian Society for Pediatric Gastroenterology, Hepatology and Nutrition with regard to IF. Data requested in this survey for children at home on Parenteral Nutrition (PN) on 1 December 2016 included patient initials, year of birth, gender, family's place of residence and underlying diagnosis determining IF.

Results: We recorded 145 CIF patients on HPN aged ≤19 years. The overall prevalence was 14.12/million inhabitants (95% CI: 9.20-18.93); the overall incidence was 1.41/million inhabitant years (95% CI: 0.53-2.20).

Conclusion: Our survey provides new epidemiological data on pediatric CIF in Italy; these data may be quantitatively useful in developing IF care strategy plans in all developed countries.
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http://dx.doi.org/10.3390/nu9111217DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707689PMC
November 2017

Re-challenge Studies in Non-celiac Gluten Sensitivity: A Systematic Review and Meta-Analysis.

Front Physiol 2017 5;8:621. Epub 2017 Sep 5.

Department of Pediatrics, Università Politecnica delle MarcheAncona, Italy.

Non-celiac gluten sensitivity (NCGS) is a clinical entity characterized by intestinal and/or extra-intestinal symptoms related to the ingestion of gluten in individuals that are not affected by either celiac disease (CD) or wheat allergy (WA). Since we do not have specific biomarkers for NCGS, the diagnosis is based on the evidence of a clear relationship between the ingestion of gluten (re-challenge) and clinical symptoms, after a remission during the gluten-free diet (GFD). Several re-challenge studies have been published so far to evaluate the real prevalence of NCGS, reporting conflicting results. In the present article, we provide a systematic review with meta-analysis of the existing literature on re-challenge studies to evaluate prevalence figures of NCGS after re-challenge procedures. All clinical trials performing a gluten re-challenge with or without a placebo control in patients with a suspected diagnosis of NCGS were included. Search results were limited to studies published in English language. No publication date or publication status restrictions were imposed. Eleven studies were included in the meta-analysis. There was a considerable heterogeneity related to different sample size, type, and amount of gluten administered, duration of challenge and different type of placebo. The overall pooled percentage of patients with a diagnosis of NCGS relapsing after a gluten challenge was 30%, ranging between 7 and 77%. The meta-analysis showed a not significant relative risk (RR) of relapse after gluten challenge as compared to placebo (RR = 0.4; 95% CI = -0.15-0.9; = 0.16). The overall pooled percentage of patients with a diagnosis of NCGS relapsing after a gluten challenge performed according to the recent Salerno criteria was significantly higher as compared to the percentage of patients relapsing after placebo (40 vs. 24%; = 0.003), with a significant RR of relapse after gluten challenge as compared to placebo (RR = 2.8; 95% CI = 1.5-5.5; = 0.002). The prevalence of NCGS after gluten re-challenge is low, and the percentage of relapse after a gluten or a placebo challenge is similar. However, a higher number of patients will be correctly classified with NCGS if applying the recent Salerno criteria.
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http://dx.doi.org/10.3389/fphys.2017.00621DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5591881PMC
September 2017