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Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

NCT ID: NCT01728610

Last Updated: 2016-01-26

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

391 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-11-30

Brief Summary

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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).

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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 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.

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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Active high

Probiotic, high dose

Group Type ACTIVE_COMPARATOR

Probiotic (Active high)

Intervention Type DIETARY_SUPPLEMENT

Higher dose of probiotic supplement

Active low

Probiotic, low dose

Group Type ACTIVE_COMPARATOR

Probiotic (Active low)

Intervention Type DIETARY_SUPPLEMENT

Lower dose of probiotic supplement

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Probiotic (Active high)

Higher dose of probiotic supplement

Intervention Type DIETARY_SUPPLEMENT

Probiotic (Active low)

Lower dose of probiotic supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Lactobacillus Lactobacillus Maltodextrin as placebo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danisco

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lea Veijola, MD

Role: PRINCIPAL_INVESTIGATOR

Herttoniemi Hospital

Arthur Ouwehand, PhD

Role: STUDY_CHAIR

DuPont Nutrition and Health

Sampo Lahtinen, PhD

Role: STUDY_CHAIR

DuPont Nutrition and Health

Anna Lyra, PhD

Role: STUDY_DIRECTOR

DuPont Nutrition and Health

Locations

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Mehiläinen Töölö

Helsinki, Helsinki, Finland

Site Status

Mehiläinen Turku

Turku, Turku, Finland

Site Status

Countries

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Finland

Other Identifiers

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IBS-2

Identifier Type: -

Identifier Source: org_study_id

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