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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
Sponsor:
Collaborators:
Mejeribrugets Forskningsfond
Arla Foods
Information provided by (Responsible Party):
Luise Molenberg Begtrup, University of Southern Denmark

Brief 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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Probiotics Dietary Supplement: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Probiotics for Irritable Bowel Syndrome
Study Start Date : January 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luise Molenberg Begtrup, Doctor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01151657     History of Changes
Other Study ID Numbers: MFF080409-2
First Posted: June 28, 2010    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: January 2009

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

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