Effect of Probiotic Supplement on Bowel Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic low

Lower dose of probiotic supplement

Group Type ACTIVE_COMPARATOR

Probiotic supplement

Intervention Type DIETARY_SUPPLEMENT

A single strain probiotic supplement given at two doses

Placebo

Group Type PLACEBO_COMPARATOR

Probiotic supplement

Intervention Type DIETARY_SUPPLEMENT

A single strain probiotic supplement given at two doses

Probiotic high

Higher dose of probiotic supplement

Group Type ACTIVE_COMPARATOR

Probiotic supplement

Intervention Type DIETARY_SUPPLEMENT

A single strain probiotic supplement given at two doses

Interventions

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Probiotic supplement

A single strain probiotic supplement given at two doses

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Lactobacillus

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes