drugset / Trial / NCT05737277

Gabapral in Pediatric IBS

NCT05737277 ↗

Unknown 20 enrolled Azienda Ospedaliera "Sant'Andrea"
RandomizedParallel-groupDouble-blindTreatment

Summary

Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder (FGID) characterized by recurrent episodes of defecation related abdominal pain associated with abnormal bowel habit. Several studies have reported significant alterations in the gut microbiota that may promote the development and persistence of IBS. Some Bifidobacterium species, mainly Bifidobacterium adolescentis, have a documented immunomodulatory effect and can modulate visceral hypersensitivity or improve the integrity of the intestinal epithelium barrier thorough its well-known ability to produce g-aminobutyric acid Thus, designed a randomised, double-blind, placebo-controlled, parallel-arm study evaluating the efficacy and safety of Bifidobacterium adolescentis PRL2019 on abdominal pain symptoms in pediatric patients with Irritative bowel sindorom

Timeline

Start
2023-03-01
Primary completion
2023-05-01
Completion
2023-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bifidobacterium adolescentis PRL2019 Unknown 20 unknown —