Skip to main content
OpenTrials
Completed

NCT Number: NCT01728610

Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

The purpose of this study is to analyse the effect of a probiotic supplement on functional intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Constipation Diarrhea Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mehiläinen Töölö, Helsinki, Finland

Loading trial locations.

About this study

The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on functional intestinal symptoms among subjects diagnosed with IBS according to Rome III criteria. Subjective assessment of bowel symptoms, quality of life, anxiety and depression and adequate relief will be assessed as with questionnaires as outcome measures. The intestinal microbiota will be analysed from faecal samples.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects aged 18 to 65 fulfilling Rome III criteria for IBS will be recruited. Sufficient general health and orientation for participating in the study is required and will be evaluated by the MDs.

Exclusion criteria

  • Diagnosed or suspected organic gastrointestinal diseases or severely impaired general health.

Treatment and study plan

Probiotic (Active high)

Dietary Supplement

Higher dose of probiotic supplement

Other names: Lactobacillus

Probiotic (Active low)

Dietary Supplement

Lower dose of probiotic supplement

Other names: Lactobacillus

Placebo

Dietary Supplement

Placebo

Other names: Maltodextrin as placebo

Primary outcomes

  1. Change in functional bowel symptoms

    Time frame: 0 weeks, 4 weeks, 12 weeks

    Validated questionnaire

Secondary outcomes

  1. Change in quality of life

    Time frame: 0 weeks, 4 weeks, 12 weeks

    Validated questionnaire

  2. Change in anxiety and depression

    Time frame: 0 weeks, 4 weeks and 12 weeks

    Validated questionnaire

  3. Adequate relief

    Time frame: Weekly over 3 month intervention

    Weekly question

  4. Change in faecal microbiota

    Time frame: 0 weeks, 4 weeks, 12 weeks

    Detection and quantification of microbes from faecal samples

  5. Safety of investigational product

    Time frame: Throughout the intervention phase

    Recording of adverse events and serious adverse events

Sponsors and collaborators

Lead sponsor

Danisco

Industry

Registry information

Official study title

Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms (IBS-2)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 20, 2012
Registry last updated
Jan 26, 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.