Effect of Bifidobacterium on Irritable Bowel Syndrome (PBIBS)

August 19, 2008 updated by: Tohoku University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of IBS with Rome II definition

Exclusion Criteria:

  • Diagnosis of serious diseases (both physically and mentally)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B
Placebo
Drug: Placebo
1.0 g of placebo, taking orally, 3 times a day for 8 weeks.
Experimental: A
Bifidobacterium breve
Drug: Bifidobacterium breve
1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adequate relief and SIBSQ
Time Frame: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Psychometric test, bowel gas, blood, and feces.
Time Frame: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tohoku University

Investigators

  • Principal Investigator: Shin Fukudo, MD, PhD, Tohoku University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Anticipated)

August 1, 2008

Study Completion (Anticipated)

September 1, 2008

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)

August 20, 2008

Last Update Submitted That Met QC Criteria

August 19, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Probio-Bifid-IBS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on Bifidobacterium breve

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe