Probiotics for Irritable Bowel Syndrome
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|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||Phase|
|Irritable Bowel Syndrome||Dietary Supplement: Probiotics Dietary Supplement: Placebo||Not Applicable|
|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|
|Actual Primary Completion Date :||June 2011|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|