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Effect of Probiotic Supplement on Bowel Function (IBS2)

Primary Purpose

Irritable Bowel Syndrome

Status

Terminated

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

Probiotic supplement

About this trial

This is an interventional supportive care trial for Irritable Bowel Syndrome focused on measuring irritable bowel syndrome, probiotic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Herttoniemi Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Probiotic low

Placebo

Probiotic high

Arm Description

Lower dose of probiotic supplement

Higher dose of probiotic supplement

Outcomes

Primary Outcome Measures

Change in functional bowel symptoms

Validated questionnaire

Secondary Outcome Measures

Change in quality of life

Validated questionnaire

Adequate relief

Weekly question

Change in faecal microbiota

Quantification of selected microbes and the intervention strain from faecal samples

Full Information

NCT ID

NCT01475929

First Posted

September 20, 2011

Last Updated

August 11, 2015

Sponsor

Danisco

1. Study Identification

Unique Protocol Identification Number

NCT01475929

Brief Title

Effect of Probiotic Supplement on Bowel Function

Acronym

IBS2

Official Title

Effect of Probiotic Supplement on Bowel Function

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Terminated

Why Stopped

Protocol violations

Study Start Date

June 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Danisco

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome, probiotic

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

149 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic low

Arm Type

Active Comparator

Arm Description

Lower dose of probiotic supplement

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Probiotic high

Arm Type

Active Comparator

Arm Description

Higher dose of probiotic supplement

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic supplement

Other Intervention Name(s)

Lactobacillus

Intervention Description

A single strain probiotic supplement given at two doses

Primary Outcome Measure Information:

Title

Change in functional bowel symptoms

Description

Validated questionnaire

Time Frame

0 weeks, 6 weeks, 12 weeks

Secondary Outcome Measure Information:

Title

Change in quality of life

Description

Validated questionnaire

Time Frame

0 weeks, 6 weeks, 12 weeks

Title

Adequate relief

Description

Weekly question

Time Frame

Weekly over 3 month intervention

Title

Change in faecal microbiota

Description

Quantification of selected microbes and the intervention strain from faecal samples

Time Frame

0 weeks, 6 weeks, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: