Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D)
- Conditions
- IBS - Irritable Bowel Syndrome
- Interventions
- Drug: Probiotic formulationDrug: Placebo
- Registration Number
- NCT05509725
- Lead Sponsor
- Lallemand Health Solutions
- Brief 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.
- Detailed Description
To monitor safety and to evaluate the efficacy of a probiotic formulation on severity of gastrointestinal symptoms (abdominal pain, abnormal defecation), anxiety, depression and quality of life in adult participants with IBS-D.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 162
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Probiotic formulation Participants in this group will be randomized to receive probiotic formulation for the following 8 weeks. Control Placebo Participants in this group will be randomized to receive placebo for the following 8 weeks.
- Primary Outcome Measures
Name Time Method Change in Defecation consistency 8 weeks Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)
Change in Abdominal Pain 8 weeks Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)
- Secondary Outcome Measures
Name Time Method Stool frequency up to 10 weeks Measured as the average number of stools per week
Change Abdominal pain intensity up to 10 weeks Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)
Abdominal discomfort up to 10 weeks Using questionnaire in participants diary
Perceived Stress 8 weeks Using the Perceived Stress Scale (PSS) grading from 0 (low stress) to 40 (high perceived stress)
Change in Irritable Bowel Syndrome Symptom Severity Scores 8 weeks Using the The irritable bowel severity scoring system (IBS-SSS)
Abnormal defecation consistency up to 10 weeks Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)
Trial Locations
- Locations (1)
Ege University Faculty of Medicine, Gastroenterology Department
🇹🇷İzmir, Turkey