About
Prior to the formation of this working team, there were no guidelines or recommendations for pharmacological trials in children with Functional Constipation, despite Functional Constipation (FC) being a common healthcare problem in children of all ages, with a worldwide prevalence ranging between 0.7% and 29.6%. Our review of the literature found that evidence for the efficacy of commonly used drugs in the treatment of childhood functional constipation (FC) was scarce and studies were often poorly designed. This Working Team’s provided recommendations through the consensus process regarding study design, patient selection, concurrent use of medications during trials, documentation, and the use of endpoints.
Publication
Recommendations for Pharmacological Clinical Trials in Children with Functional Constipation: The Rome foundation Pediatric Subcommittee on Clinical Trials
Koppen, I. J. N., Saps, M., Lavigne, J. V., Nurko, S., Taminiau, J. A. J. M., Di Lorenzo, C., & Benninga, M. A.
(2018). Neurogastroenterology & Motility, 30(4), e13294.
Abstract
Members of the Working Team
Chair
Miguel Saps, MD
Division of Pediatric Gastroenterology, Hepatology & Nutrition
Nationwide Children’s Hospital
Columbus, OH, USA
Marc Benninga, MD
Department of Pediatric Gastroenterology and Nutrition
Emma Children’s Hospital/Academic Medical Center
Amsterdam, The Netherlands
Carlo Di Lorenzo, MD
Division of Pediatric Gastroenterology, Hepatology & Nutrition
Nationwide Children’s Hospital
Columbus, OH, USA
Ilan Koppen, MD, PhD
Department of Pediatric Gastroenterology and Nutrition
Emma Children’s Hospital/Academic Medical Center
Amsterdam, The Netherlands
John Lavigne, PhD
Department of Child and Adolescent Psychiatry
Ann & Robert H. Lurie Children’s Hospital of Chicago
Chicago, IL, USA
Feinberg School of Medicine
Northwestern University
Chicago, IL, USA
Mary Ann and J. Milburn Smith Child Health Research Program
Chicago, IL, USA
Children’s Hospital of Chicago Research Center
Chicago, IL, USA
Samuel Nurko, MD, MPHCenter for Motility and Functional Gastrointestinal Disorders
Boston Children’s Hospital
Boston, MA, USA
Johannes Taminiau, MD
Member of the Pediatric Committee (PDCO)
European Medicines Agency
London, UK