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Effect of Bifidobacterium on Irritable Bowel Syndrome

NCT ID: NCT00737841

Last Updated: 2008-08-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-09-30

Brief Summary

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There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients.

Detailed Description

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There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients. IBS patients will be enrolled via advertisement. Any IBS subtypes will not be rejected. They will take either 1.0 g of Bifidobacterium breve 3 times a day or same amount of placebo for 8 weeks. IBS symptoms and allied markers will be checked before, during, and after the administration.

Conditions

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Irritable Bowel Syndrome

Keywords

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stress brain-gut interactions visceral perception gastrointestinal motility emotion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Bifidobacterium breve

Group Type EXPERIMENTAL

Bifidobacterium breve

Intervention Type DRUG

1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks.

B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1.0 g of placebo, taking orally, 3 times a day for 8 weeks.

Interventions

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Bifidobacterium breve

1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks.

Intervention Type DRUG

Placebo

1.0 g of placebo, taking orally, 3 times a day for 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of IBS with Rome II definition

Exclusion Criteria

* Diagnosis of serious diseases (both physically and mentally)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tohoku University

OTHER

Sponsor Role lead

Responsible Party

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Tohoku University Graduate School of Medicine

Principal Investigators

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Shin Fukudo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tohoku University

Locations

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Tohoku University Graduate School of Medicine

Sendai, Miyagi, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Shin Fukudo, MD, PhD

Role: CONTACT

Phone: +81-22-717-8214

Email: [email protected]

Machiko Watabe

Role: CONTACT

Phone: +81-22-717-8162

Email: [email protected]

Facility Contacts

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Shin Fukudo, MD, PhD

Role: primary

Machiko Watabe

Role: backup

Other Identifiers

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Probio-Bifid-IBS

Identifier Type: -

Identifier Source: org_study_id