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Effect of Bifidobacterium on Irritable Bowel Syndrome (PBIBS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Tohoku University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tohoku University
ClinicalTrials.gov Identifier:
NCT00737841
First received: August 18, 2008
Last updated: August 19, 2008
Last verified: August 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014