Probiotics for Irritable Bowel Syndrome

July 18, 2016 updated by: Norwegian University of Science and Technology

Lactobacillus Plantarum MF 1298 vs Placebo for Irritable Bowel Syndrome.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Oppland
      • Gjovik, Oppland, Norway, N-2819
        • Innlandet Hospital HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfactory relief of abdominal symptoms
Time Frame: 11 weeks
relief of symptoms recorded on diary cards
11 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graded measurement of abdominal symptoms
Time Frame: 11 weeks
IBS sum score
11 weeks
Fecal bacterial count
Time Frame: 11 weeks
11 weeks
Abdominal gas
Time Frame: 11 weeks
11 weeks
Immunological parameters
Time Frame: 11 weeks
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Sykehuset Innlandet HF
Norwegian Foundation for Health and Rehabilitation
Norwegian Food Research
Gilde

Investigators

  • Principal Investigator: Per G Farup, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

April 1, 2006

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

July 24, 2006

First Submitted That Met QC Criteria

July 24, 2006

First Posted (ESTIMATE)

July 25, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 4.2005.2284

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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