Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D)

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to monitor safety and to evaluate the efficacy of a probiotic formulation on abdominal pain, abnormal defecation, comorbid mood disorders (anxiety and depression) as well as general quality of life in adults with IBS-D.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lallemand Health Solutions

Criteria

Inclusion Criteria:

• Experiencing symptoms of IBS-D

• Having a diagnosis of IBS-D based on Rome IV criteria

• Participants with symptom onset at least 6 months before diagnosis

• Having a normal colonoscopy result in their medical file

Exclusion Criteria:

• A history of inflammatory or immune-mediated gastrointestinal diseases

• Diagnosed with a co-existing organic gastrointestinal disease which can affect the study

• Currently undergoing a treatment for other severe conditions such as coronary disease, neurological disorder, kidney or liver disease,

• Currently diagnosed with an eating disorder,

• Having undergone any abdominal surgery including cholecystectomy, with the exception of hernia repair or appendectomy

• Currently diagnosed with any mood- or anxiety-related disorder, major psychiatric illness, or participants with a history of suicidal ideation, or current suicidal ideation,

• Regular use of anti-diarrhea medications and laxatives however occasional use is permitted (≤ than once a month); if current use is > once per month a one month wash out is needed,

• Unwilling to avoid the use of antidiarrheal or laxative medication on an "as-needed basis" during the full length of the study,

• Pregnant, breast-feeding or planning on becoming pregnant.