J Pediatr Gastroenterol Nutr 2021 Jun 1. Epub 2021 Jun 1.
Division of Pediatric Gastroenterology, Hepatology and Nutrition, Holtz Children's Hospital, Miami, FL; University of Miami, Miller School of Medicine, Miami, FL Center for Motility and Functional Gastrointestinal Disorders, Boston Children's Hospital, Boston, MA; Professor of Pediatrics, Harvard Medical School, Boston, MA Department of Pediatric Gastroenterology and Nutrition, Emma Children's Hospital, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands Division of Pediatric Gastroenterology, Hepatology and Nutrition at Nationwide Children's Hospital, Nationwide Children's Hospital, Columbus, OH GI Care for Kids, Atlanta, GA; Neurogastroenterology and Motility Program, Children's Healthcare of Atlanta, Atlanta, GA Neurogastroenterology and Motility Unit, Department of Paediatric Gastroenterology, Great Ormond Street Hospital NHS Foundation Trust, London, United Kingdom; UCL Great Ormond Street Institute of Child Health, London, United Kingdom Paediatric Gastroenterology, Hepatology and Liver Transplant, Queensland Children's Hospital, Brisbane, Australia Division of Regulatory Operations for Immunology and Inflammation, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Division of Gastroenterology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
Abstract: Pediatric functional gastrointestinal disorders including irritable bowel syndrome with constipation and functional constipation are common conditions in childhood, but no drugs are FDA approved for chronic use in pediatric patients with these disorders. Despite efforts to better standardize the diagnosis of these conditions in children (including recent modifications to the Rome criteria), conducting pediatric clinical trials to support drug approval remains a challenge. In March 2018, the U. Read More