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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D): A Multicenter, Randomized, Prospective, Placebo-Controlled, Double-Blind, Phase IV Clinical Study

Conditions
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IBS - Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Probiotic formulation
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants in this group will be randomized to receive probiotic formulation for the following 8 weeks. | Drug: Probiotic formulation<br>* Participants will be asked to take 2 doses daily<br>|
| Placebo Comparator: Control<br>Participants in this group will be randomized to receive placebo for the following 8 weeks. | Drug: Placebo<br>* Participants will be asked to take 2 doses daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Abdominal Pain | Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible) | 8 weeks | 
| Change in Defecation consistency | Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Abdominal pain intensity | Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible) | up to 10 weeks | 
| Abnormal defecation consistency | Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea) | up to 10 weeks | 
| Stool frequency | Measured as the average number of stools per week | up to 10 weeks | 
| Abdominal discomfort | Using questionnaire in participants diary | up to 10 weeks | 
| Perceived Stress | Using the Perceived Stress Scale (PSS) grading from 0 (low stress) to 40 (high perceived stress) | 8 weeks | 
| Change in Irritable Bowel Syndrome Symptom Severity Scores | Using the The irritable bowel severity scoring system (IBS-SSS) | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS-D, Probiotics