Effects of Cultura Yoghurt in Irritable Bowel Syndrome (IBS) Patients on Intestinal and Immunological Changes

Study Overview
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Brief Summary
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To determine the effect of cultura probiotic yoghurt on number of responders to treatment during 8 weeks of treatment in comparison to placebo. To determine the effect of cultura yoghurt on change in total score of (IBS) irritable bowel syndrome severity index during 8 weeks of treatment in comparison to placebo in IBS out patients.

Detailed Description
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Recent research has shown taht probiotic may give positive effect on symptoms among patients with (IBS) Irritable Bowel Syndrome. The mechanism behind the positive effect are not known but a positive effect on different cytokines are a possible mechanism. Also effect on the large intestine bacterial mass could be of importance.

Official Title
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Effects of Cultura Yoghurt on Symptoms Intestinal Flora and Immunological Changes in Patients With Irritable Bowel Syndrome(IBS)

Conditions
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Irritable Bowel Syndrome, Relief of Irritable Bowel Syndrome Symptoms, Quality of Life

Intervention / Treatment
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* Other: Arla Yoghurt with no probiotic
* Other: Probiotic yoghurt (Cultura)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed consent to participate age 18-70 years IBS according to Rome II criteria - Exclusion Criteria: Participation in a clinical study one month prior to screening visit and throughout the study. Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator. Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the investigator. Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the investigator. Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the investigator. Severe psychiatric disease as judged by the investigator. Previous history of drug or alcohol abuse six months prior to screening. Intolerance or allergy against milk products or gluten. Use of other probiotic products (according to sponsor's list) 2 weeks prior to the study and throughout the study. Consumption of antibiotic drugs 1 month prior to screening and throughout the study. Consumption of cortisone, NSAID or other anti-inflammatory drugs on a regular basis 2 weeks prior to screening and throughout the study. Pregnant or lactating or wish to become pregnant during the period of the study. Lack of suitability for participation in the study for any reason as judged by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic yoghurt (Cultura)<br>Cultura yoghurt containing: L bulgaricus, S thermophilus | Other: Probiotic yoghurt (Cultura)<br>* 200 ml per day<br>|
| Placebo Comparator: Yoghurt with no probiotic<br> | Other: Arla Yoghurt with no probiotic<br>* two servings of 200 ml of investigational products per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of IBS symptoms | The primary endpoint of this study was the proportions of patients reporting adequate relief of their IBS symptoms at least 50 % of the weeks during the treatment period | 6 weeks intervention and 6 weeks follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on gastrointestinal and extraintestinal symptoms | effects of the investigational products on GI and extraintestinal symptoms assessed with the weekly IBS SSI questionnaire and the scores from the daily questions of the GI symptom questionnaire as weel as the effect on psychological symptoms and quality of life. | September 2005 to May 2006 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS (Irritable Bowel Syndrome), Probiotic yoghurt, Symptom severity