Probiotics for Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Collaborators:
Norwegian Food Research
Gilde, Norway AB
Norwegian Foundation for Health and Rehabilitation
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00355810
First received: July 24, 2006
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

This randomised, double blind, cross-over study compares the effect (symptoms, fecal bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum MF 1298 with placebo in patients with irritable bowel syndrome. The results are related to dietary habits, food intolerance and food allergy.


Condition Intervention
Functional Gastrointestinal Disorders
Irritable Bowel Syndrome
Dietary Supplement: placebo followed by Lactobacillus plantarum MF 1298
Dietary Supplement: Lactobacillus plantarum MF1298 followed by placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Lactobacillus Plantarum MF 1298 vs Placebo for Irritable Bowel Syndrome.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Satisfactory relief of abdominal symptoms [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
    relief of symptoms recorded on diary cards


Secondary Outcome Measures:
  • Graded measurement of abdominal symptoms [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
    IBS sum score

  • Fecal bacterial count [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Abdominal gas [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Immunological parameters [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: January 2006
Study Completion Date: December 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: placebo followed by probiotic
placebo, then washout period, then Lactobacillus plantarum MF1298
Dietary Supplement: placebo followed by Lactobacillus plantarum MF 1298
placebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks
Other Name: probiotic
Experimental: probiotic followed by placebo
Lactobacillus plantarum MF1298, then washout period, then placebo
Dietary Supplement: Lactobacillus plantarum MF1298 followed by placebo
Lactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks
Other Name: probiotic

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Irritable bowel syndrome according to the Rome II criteria
  • regular symptoms

Exclusion Criteria:

  • Use of probiotics last three weeks
  • pregnancy
  • lactation
  • co-existing other gastrointestinal disorders
  • use of laxatives and antibiotics within last 5 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355810

Locations
Norway
Innlandet Hospital HF
Gjovik, Oppland, Norway, N-2819
Sponsors and Collaborators
Norwegian University of Science and Technology
Norwegian Food Research
Gilde, Norway AB
Norwegian Foundation for Health and Rehabilitation
Sykehuset Innlandet HF
Investigators
Principal Investigator: Per G Farup, PhD Norwegian University of Science and Technology
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00355810     History of Changes
Other Study ID Numbers: REK 4.2005.2284
Study First Received: July 24, 2006
Last Updated: September 29, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Keywords provided by Norwegian University of Science and Technology:
Probiotics

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

ClinicalTrials.gov processed this record on October 20, 2014