Effect of Bifidobacterium on Irritable Bowel Syndrome

Effect of Bifidobacterium on Irritable Bowel Syndrome

Sponsors

Lead Sponsor: Tohoku University

Source Tohoku University
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.

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.

Overall Status Unknown status
Start Date January 2006
Completion Date September 2008
Primary Completion Date August 2008
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Adequate relief and SIBSQ 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
Secondary Outcome
Measure Time Frame
Psychometric test, bowel gas, blood, and feces. 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
Enrollment 50
Condition
Intervention

Intervention Type: Drug

Intervention Name: Bifidobacterium breve

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

Arm Group Label: A

Intervention Type: Drug

Intervention Name: Placebo

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

Arm Group Label: B

Eligibility

Criteria:

Inclusion Criteria: - Diagnosis of IBS with Rome II definition Exclusion Criteria: - Diagnosis of serious diseases (both physically and mentally)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Shin Fukudo, MD, PhD Principal Investigator Tohoku University
Overall Contact

Last Name: Shin Fukudo, MD, PhD

Phone: +81-22-717-8214

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Tohoku University Graduate School of Medicine Shin Fukudo, MD, PhD +81-22-717-8214 [email protected]
Location Countries

Japan

Verification Date

August 2008

Responsible Party

Name Title: Shin Fukudo

Organization: Tohoku University Graduate School of Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: A

Type: Experimental

Description: Bifidobacterium breve

Label: B

Type: Placebo Comparator

Description: Placebo

Acronym PBIBS
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov