Effect of Bifidobacterium on Irritable Bowel Syndrome - Full Text View

Purpose

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.

Condition	Intervention
Irritable Bowel Syndrome	Drug: Bifidobacterium breve Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Effect of Bifidobacterium on Irritable Bowel Syndrome

Further study details as provided by Tohoku University:

Primary Outcome Measures:

Adequate relief and SIBSQ [ Time Frame: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Psychometric test, bowel gas, blood, and feces. [ Time Frame: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	January 2006
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Bifidobacterium breve	Drug: Bifidobacterium breve 1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks.
Placebo Comparator: B Placebo	Drug: Placebo 1.0 g of placebo, taking orally, 3 times a day for 8 weeks.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of IBS with Rome II definition

Exclusion Criteria:

Diagnosis of serious diseases (both physically and mentally)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737841

Contacts

Contact: Shin Fukudo, MD, PhD	+81-22-717-8214	sfukudo@mail.tains.tohoku.ac.jp
Contact: Machiko Watabe	+81-22-717-8162	wmachiko@mail.tains.tohoku.ac.jp

Locations

Japan
Tohoku University Graduate School of Medicine	Recruiting
Sendai, Miyagi, Japan, 980-8575
Contact: Shin Fukudo, MD, PhD +81-22-717-8214 sfukudo@mail.tains.tohoku.ac.jp
Contact: Machiko Watabe +81-22-717-8162 wmachiko@mail.tains.tohoku.ac.jp

Sponsors and Collaborators

Tohoku University

Investigators

Principal Investigator:

Shin Fukudo, MD, PhD

Tohoku University

More Information

No publications provided

Responsible Party:	Shin Fukudo, Tohoku University Graduate School of Medicine
ClinicalTrials.gov Identifier:	NCT00737841 History of Changes
Other Study ID Numbers:	Probio-Bifid-IBS
Study First Received:	August 18, 2008
Last Updated:	August 19, 2008
Health Authority:	Japan: Institutional Review Board

Keywords provided by Tohoku University:

stress
brain-gut interactions
visceral perception
gastrointestinal motility
emotion

Additional relevant MeSH terms:

Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases

Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013

Effect of Bifidobacterium on Irritable Bowel Syndrome (PBIBS)