NCT00737841

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

August 20, 2008

Status Verified

August 1, 2008

Enrollment Period

2.6 years

First QC Date

August 18, 2008

Last Update Submit

August 19, 2008

Conditions

Irritable Bowel Syndrome

Keywords

stressbrain-gut interactionsvisceral perceptiongastrointestinal motilityemotion

Outcome Measures

Primary Outcomes (1)

  • Adequate relief and SIBSQ

    2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment

Secondary Outcomes (1)

  • Psychometric test, bowel gas, blood, and feces.

    2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment

Study Arms (2)

A

EXPERIMENTAL

Bifidobacterium breve

Drug: Bifidobacterium breve

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Bifidobacterium breveDRUG

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

A
PlaceboDRUG

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

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of IBS with Rome II definition

You may not qualify if:

  • Diagnosis of serious diseases (both physically and mentally)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tohoku University Graduate School of Medicine

Sendai, Miyagi, 980-8575, Japan

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Shin Fukudo, MD, PhD

    Tohoku University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shin Fukudo, MD, PhD

CONTACT

+81-22-717-8214sfukudo@mail.tains.tohoku.ac.jp

Machiko Watabe

CONTACT

+81-22-717-8162wmachiko@mail.tains.tohoku.ac.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

January 1, 2006

Primary Completion

August 1, 2008

Study Completion

September 1, 2008

Last Updated

August 20, 2008

Record last verified: 2008-08

Locations

JP(1)