Probiotics for Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotics

• Registration Number: NCT01151657
• Lead Sponsor: University of Southern Denmark

Brief Summary

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

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.

Study Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-06-25
• Study First Posted: 2010-06-28
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-10-24
• Last Update Posted: 2011-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Capsules containing maltodextrin.
Probiotics	Probiotics	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.

Primary Outcome Measures

Name	Time	Method
Adequate relief	Every month for 12 months	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.

Secondary Outcome Measures

Name	Time	Method
gastrointestinal symptoms	Every month for 12 months	We use the questionnaires GSRS-IBS and GSRS. The patients are asked every month (in monthly letters) for 12 months.

Trial Locations

Locations (1)

Research Unit for General Practice, Department of gastroenterology, Odense University hospital; 🇩🇰 Odense, Denmark