Skip to main content
OpenTrials
Completed

NCT Number: NCT00355810

Probiotics 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Functional Gastrointestinal Disorders Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Innlandet Hospital HF

Gjøvik, Oppland, N-2819, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

placebo followed by Lactobacillus plantarum MF 1298

Dietary Supplement

placebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks

Other names: probiotic

Lactobacillus plantarum MF1298 followed by placebo

Dietary Supplement

Lactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks

Other names: probiotic

Primary outcomes

  1. Satisfactory relief of abdominal symptoms

    Time frame: 11 weeks

    relief of symptoms recorded on diary cards

Secondary outcomes

  1. Graded measurement of abdominal symptoms

    Time frame: 11 weeks

    IBS sum score

  2. Fecal bacterial count

    Time frame: 11 weeks

  3. Abdominal gas

    Time frame: 11 weeks

  4. Immunological parameters

    Time frame: 11 weeks

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

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

Registry information

Official study title

Lactobacillus Plantarum MF 1298 vs Placebo for Irritable Bowel Syndrome.

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jul 25, 2006
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.