Trial | NCT01151657  Report issue

Official Title

Probiotics for Irritable Bowel Syndrome

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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.
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 Started
Jan 31
2009
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Last Update
Oct 25
2011
Estimate

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.

Dietary Supplement Placebo

Placebo capsules containing maltodextrin

Placebo Placebo Comparator

Capsules containing maltodextrin.

Probiotics Experimental

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.

Criteria 

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
No Results Posted