Probiotics for Irritable Bowel Syndrome

This study has been completed.

Sponsors and Collaborators:	Norwegian University of Science and Technology Norwegian Food Research Gilde, Norway AB Norwegian Foundation for Health and Rehabilitation Sykehuset Innlandet HF
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00355810

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	Phase
Functional Gastrointestinal Disorders Irritable Bowel Syndrome	Drug: Lactobacillus plantarum MF 1298	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Lactobacillus Plantarum MF 1298 vs Placebo for Irritable Bowel Syndrome.

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

Primary Outcome Measures:

Satisfactory relief of abdominal symptoms

Secondary Outcome Measures:

Graded measurement of abdominal symptoms
Fecal bacterial count
Abdominal gas
Immunological parameters

Estimated Enrollment:	16
Study Start Date:	January 2006
Study Completion Date:	December 2006
Estimated Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

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 and regular symptoms -

Exclusion Criteria:

Use of probiotics last three weeks, pregnancy, lactation, co-existing other gastrointestinal disorders, and use of laxantia and antibiotics last 5 weeks.

Contacts and Locations

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

Locations

Norway, Oppland
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:

Solveig C Ligaarden, MD

Innlandet Hospital HF

More Information

Responsible Party:	Innlandet Hospital HF ( MD Solveig Ligaarden )
Study ID Numbers:	REK 4.2005.2284
Study First Received:	July 24, 2006
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00355810
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services; Norway: Directorate for Health and Social Affairs

Keywords provided by Norwegian University of Science and Technology:

Probiotics
Clinical Trial

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases

Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 14, 2009