Probiotics for Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Probiotics for Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151657
• Other study ID #: MFF080409-2
• Status: Completed
• Phase: N/A
• First received: June 25, 2010
• Last updated: October 24, 2011
• Start date: January 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2009
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Probiotics
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.
• Placebo
Placebo capsules containing maltodextrin

Locations

Country	Name	City	State
Denmark	Research Unit for General Practice, Department of gastroenterology, Odense University hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Arla Foods, Mejeribrugets Forskningsfond

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No