Gabapral in Pediatric IBS

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera "Sant'Andrea"

Criteria

Inclusion Criteria

• IBS subtypes 4 -17 years of age,

• negative fecal calprotectine

• negative anti-transglutaminasi antibodies.

Exclusion Criteria:

• the current use of nonsteroidal anti-inflammatory drugs, corticosteroids and mast cell stabilisers,

• the use of topical or systemic antibiotics in the last month,

• use of stimulant laxatives,

• major abdominal surgery,

• inflammatory bowel disease,

• infectious diarrhoea,

• allergic diseases a

• psychiatric disorders.