Probiotics for Irritable Bowel Syndrome
|ClinicalTrials.gov Identifier: NCT01151657|
Recruitment Status : Completed
First Posted : June 28, 2010
Last Update Posted : October 25, 2011
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.
|Condition or disease||Intervention/treatment|
|Irritable Bowel Syndrome||Dietary Supplement: Probiotics Dietary Supplement: Placebo|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Probiotics for Irritable Bowel Syndrome|
|Study Start Date :||January 2009|
|Primary Completion Date :||June 2011|
|Study Completion Date :||June 2011|
Placebo Comparator: Placebo
Capsules containing maltodextrin.
Dietary Supplement: Placebo
Placebo capsules containing maltodextrin
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
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.
- Adequate relief [ Time Frame: 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.
- gastrointestinal symptoms [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151657
|Research Unit for General Practice, Department of gastroenterology, Odense University hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Ove B Schaffalitzky de Muckadell, Dr.Med, Professor||Department of gastroenterology, Odense University hospital|