Effect of Probiotic Supplement on Bowel Function

Study Overview
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Brief Summary
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The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.

Detailed Description
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The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on symptoms of irritable bowel syndrome (IBS). Fulfillment of Rome III criteria will be used as inclusion criterion. Subjective assessment of bowel symptoms, IBS-related quality of life and adequate relief will be assessed as outcome measures.

Official Title
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Effect of Probiotic Supplement on Bowel Function

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Probiotic supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged 18 to 65 with functional bowel symptoms and fulfilling Rome III criteria for IBS will be recruited. Sufficient general health and orientation for participating in the study is required and will be evaluated by the MDs. Exclusion Criteria: Diagnosed or suspected organic gastrointestinal diseases or severely impaired general health are exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Probiotic low<br>Lower dose of probiotic supplement | Dietary Supplement: Probiotic supplement<br>* A single strain probiotic supplement given at two doses<br>* Other names: Lactobacillus;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Probiotic supplement<br>* A single strain probiotic supplement given at two doses<br>* Other names: Lactobacillus;|
| Active Comparator: Probiotic high<br>Higher dose of probiotic supplement | Dietary Supplement: Probiotic supplement<br>* A single strain probiotic supplement given at two doses<br>* Other names: Lactobacillus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional bowel symptoms | Validated questionnaire | 0 weeks, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | Validated questionnaire | 0 weeks, 6 weeks, 12 weeks | 
| Adequate relief | Weekly question | Weekly over 3 month intervention | 
| Change in faecal microbiota | Quantification of selected microbes and the intervention strain from faecal samples | 0 weeks, 6 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irritable bowel syndrome, probiotic