Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

Study Overview
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Brief Summary
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The purpose of this study is to analyse the effect of a probiotic supplement on functional intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).

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 functional intestinal symptoms among subjects diagnosed with IBS according to Rome III criteria. Subjective assessment of bowel symptoms, quality of life, anxiety and depression and adequate relief will be assessed as with questionnaires as outcome measures. The intestinal microbiota will be analysed from faecal samples.

Official Title
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Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms (IBS-2)

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Probiotic (Active high)
* Dietary Supplement: Probiotic (Active low)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged 18 to 65 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.

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: Active high<br>Probiotic, high dose | Dietary Supplement: Probiotic (Active high)<br>* Higher dose of probiotic supplement<br>* Other names: Lactobacillus;|
| Active Comparator: Active low<br>Probiotic, low dose | Dietary Supplement: Probiotic (Active low)<br>* Lower dose of probiotic supplement<br>* Other names: Lactobacillus;|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Placebo<br>* Other names: Maltodextrin as placebo;|

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, 4 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | Validated questionnaire | 0 weeks, 4 weeks, 12 weeks | 
| Change in anxiety and depression | Validated questionnaire | 0 weeks, 4 weeks and 12 weeks | 
| Adequate relief | Weekly question | Weekly over 3 month intervention | 
| Change in faecal microbiota | Detection and quantification of microbes from faecal samples | 0 weeks, 4 weeks, 12 weeks | 
| Safety of investigational product | Recording of adverse events and serious adverse events | Throughout the intervention phase | 

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