Effect of Probiotic Supplement on Bowel Function (IBS2)

August 11, 2015 updated by: Danisco
The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on symptoms of irritable bowel syndrome (IBS). Fulfillment of Rome III criteria will be used as inclusion criterion. Subjective assessment of bowel symptoms, IBS-related quality of life and adequate relief will be assessed as outcome measures.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 2

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

  • Finland
      • Helsinki, Finland, 00800
        • Herttoniemi Hospital

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects aged 18 to 65 with functional bowel symptoms and 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 are exclusion criteria.

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Probiotic supplement
A single strain probiotic supplement given at two doses
Other Names:
  • Lactobacillus
ACTIVE_COMPARATOR: Probiotic low
Lower dose of probiotic supplement
Dietary supplement: Probiotic supplement
A single strain probiotic supplement given at two doses
Other Names:
  • Lactobacillus
ACTIVE_COMPARATOR: Probiotic high
Higher dose of probiotic supplement
Dietary supplement: Probiotic supplement
A single strain probiotic supplement given at two doses
Other Names:
  • Lactobacillus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional bowel symptoms
Time Frame: 0 weeks, 6 weeks, 12 weeks
Validated questionnaire
0 weeks, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life
Time Frame: 0 weeks, 6 weeks, 12 weeks
Validated questionnaire
0 weeks, 6 weeks, 12 weeks
Adequate relief
Time Frame: Weekly over 3 month intervention
Weekly question
Weekly over 3 month intervention
Change in faecal microbiota
Time Frame: 0 weeks, 6 weeks, 12 weeks
Quantification of selected microbes and the intervention strain from faecal samples
0 weeks, 6 weeks, 12 weeks

Collaborators and Investigators

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

Sponsor

Danisco

Investigators

  • Study Chair: Arthur Ouwehand, PhD, Danisco
  • Principal Investigator: Lea Veijola, MD, Helsinki Health Centre
  • Study Director: Anneli Tarpila, PhD, Danisco

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

June 1, 2011

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (ESTIMATE)

November 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBS2

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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