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Probiotics for Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Collaborators:
Mejeribrugets Forskningsfond
Arla Foods
Information provided by (Responsible Party):
Luise Molenberg Begtrup, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01151657
First received: June 25, 2010
Last updated: October 24, 2011
Last verified: January 2009
History of Changes
  Purpose

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 Intervention
Irritable Bowel Syndrome
 Dietary Supplement: Probiotics
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Probiotics for Irritable Bowel Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Adequate relief [ Time Frame: Every month for 12 months ] [ Designated as safety issue: No ]
    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:
  • gastrointestinal symptoms [ Time Frame: Every month for 12 months ] [ Designated as safety issue: No ]
    We use the questionnaires GSRS-IBS and GSRS. The patients are asked every month (in monthly letters) for 12 months.


Estimated Enrollment: 150
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Capsules containing maltodextrin.
 Dietary Supplement: Placebo
Placebo capsules containing maltodextrin
Experimental: 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.
 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01151657

Locations
Denmark
Research Unit for General Practice, Department of gastroenterology, Odense University hospital
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Mejeribrugets Forskningsfond
Arla Foods
Investigators
Principal Investigator: Ove B Schaffalitzky de Muckadell, Dr.Med, Professor Department of gastroenterology, Odense University hospital
  More Information

No publications provided

Responsible Party: Luise Molenberg Begtrup, Doctor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01151657     History of Changes
Other Study ID Numbers: MFF080409-2
Study First Received: June 25, 2010
Last Updated: October 24, 2011
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
IBS
Irritable bowel syndrome
Probiotics
Treatment
Adequate relief

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013