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Effect of Bifidobacterium on Irritable Bowel Syndrome (PBIBS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Tohoku University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737841
First Posted: August 20, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tohoku University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Shin Fukudo, Tohoku University Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT00737841     History of Changes
Other Study ID Numbers: Probio-Bifid-IBS
First Submitted: August 18, 2008
First Posted: August 20, 2008
Last Update Posted: October 12, 2017
Last Verified: August 2008

Keywords provided by Tohoku University:
stress
brain-gut interactions
visceral perception
gastrointestinal motility
emotion

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases