Vetal Laban Intervention Trial Assessing Bowel Symptoms

Study Overview
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Brief Summary
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A two month intervention trial assessing the effect of Vetal Laban containing L. acidophilus on enhancing functional bowel wellbeing among subjects with irritable bowel syndrome (IBS).

Official Title
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A Double-Blind Placebo-Controlled Randomized Clinical Trial Assessing the Effect of 2 Month Consumption of Vetal Laban Including L. Acidophilus on Functional Gastrointestinal Symptoms Among Subjects Fulfilling Rome III Criteria for IBS

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Vetal Laban active
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 18 to 65 years Subjects fulfilling Rome III criteria for IBS Sufficient health and orientation for participating in the trial Obtained his/her informed consent after verbal and written information. Have a high probability for compliance with and completion of the study. Body Mass Index (BMI) between 19 and 35. Exclusion Criteria: Diagnosed or suspected organic gastrointestinal disease (i.e. colitis, Crohn's disease, celiac disease, major bowel surgery, recurrent diverticulitis) or severely impaired general health including cancer and cancer therapy. Lactose intolerance Unwillingness to refrain from probiotic use during the trial Use of antibiotics within the 3 preceding months prior to recruitment Pregnant, planning pregnancy or lactating Expected major lifestyle changes related to nutrition, exercise, travelling etc. Participation in a clinical trial with an investigational product or drug within 3 months prior to screening. Substance abuse Subjects unable to read and understand the questionnaires

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vetal Laban active<br>Vetal Laban with L. acidophilus | Dietary Supplement: Vetal Laban active<br>* Dairy product with probiotic<br>* Other names: Vetal Laban, Lactobacillus acidophilus;|
| Placebo Comparator: Placebo<br>Vetal Laban -like product without L. acidophilus | Dietary Supplement: Placebo<br>* Dairy product without probiotic<br>* Other names: Vetal Laban-like product without L. acidophilus;|

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 | week 0, 4, 8, 12 and 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in adequate relief of bowel symptoms | Weekly question | weekly from week 4 to week 12 | 
| change in stool defecation frequency | Validated scale | week 0, 4, 8, 12 and 16 | 
| change in stool microbiota | molecular analyses | week 4, 8, 12 and 16 | 
| change in prevalence of adverse events | Recording of adverse and serious adverse events | continuous from week 0 to 16 | 
| change in stool consistency | Validated scale | week 0, 4, 8, 12 and 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, bowel function, probiotic