Probiotics for Irritable Bowel Syndrome

Study Overview
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Brief Summary
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The study aims to investigate the effect of probiotics on IBS-patients symptoms compared to placebo, when given for 6 months. By draw the investigators give IBS patients, in the age of 18-50 years, capsules with either probiotics or placebo. The patients are to take 2x2 capsules / day for 6 months. The patients are followed for 1 year. They are seen after 3, 6 and 12 months, and are followed by means of monthly letters. The capsules contain 3 different probiotic strains - Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12. The dose is 2 x 109 - 10 x 109 CFU/capsule. The hypothesis is, that there is a clinical difference between the group receiving probiotics and the group receiving placebo.

Detailed Description
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Background: In management of IBS, no treatments have showed great efficacy. IBS is a non-fatal disease, so safety is a high priority in the choice of treatment. Probiotics is a dietary supplement and have no adverse effects. In some studies it has shown beneficial effect on some of the IBS patients symptoms, but some of the results are questionable. The studies have to be of longer duration, with more patients and the probiotics have to be capsules instead of milk based drinks.

Official Title
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Probiotics for Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fulfill ROME III criteria age 18-50 years signed informed content Exclusion Criteria: Danger signals (fever, anaemia, weightloss, blod in stools, predisposition for CRC or IBD) abnormal physical examination comorbidity abuse lacking ability to talk and understand danish pregnancy For patients > 40 years. Changed bowel habits, with duration > 3 weeks, but < 1 year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Capsules containing maltodextrin. | Dietary Supplement: Placebo<br>* Placebo capsules containing maltodextrin<br>|
| Experimental: Probiotics<br>Probiotics containing the 3 strains: Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 og Bifidobacterium Bb12 in the dose of 2 x 109 - 10 x 109 CFU/capsule. The patients are to take 2x2 capsules a day. | Dietary Supplement: Probiotics<br>* Capsules with probiotics containing the strains : Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 og Bifidobacterium Bb12. Dose/capsule : 2 x 109 - 10 x 109 CFU.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate relief | The patients are asked In the last seven days, have you had adequate relief of your IBS symptoms? . They are asked this question every month ( in a monthly letter) for 12 months. | Every month for 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastrointestinal symptoms | We use the questionnaires GSRS-IBS and GSRS. The patients are asked every month (in monthly letters) for 12 months. | Every month for 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, Irritable bowel syndrome, Probiotics, Treatment, Adequate relief