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NCT00737841 Clinical Trial

Effect of Bifidobacterium on Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— PBIBS  

Official title:
Effect of Bifidobacterium on Irritable Bowel Syndrome

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00737841
Other study ID # Probio-Bifid-IBS
Secondary ID
Status Unknown status
Phase N/A
First received August 18, 2008
Last updated August 19, 2008
Start date January 2006
Est. completion date September 2008

Study information
Verified date August 2008
Source Tohoku University
Contact Shin Fukudo, MD, PhD
Phone +81-22-717-8214
Email sfukudo@mail.tains.tohoku.ac.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 50
Est. completion date September 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of IBS with Rome II definition

Exclusion Criteria:

- Diagnosis of serious diseases (both physically and mentally)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bifidobacterium breve
1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks.
• Placebo
1.0 g of placebo, taking orally, 3 times a day for 8 weeks.

Locations
Country Name City State
Japan Tohoku University Graduate School of Medicine Sendai Miyagi

Sponsors (1)
Lead Sponsor Collaborator
Tohoku University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adequate relief and SIBSQ 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
Secondary Psychometric test, bowel gas, blood, and feces. 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
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