ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Bifidobacterium on Irritable Bowel Syndrome (PBIBS)

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.
ClinicalTrials.gov Identifier: NCT00737841
Recruitment Status : Unknown
Verified August 2008 by Tohoku University.
Recruitment status was:  Recruiting
First Posted : August 20, 2008
Last Update Posted : August 20, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Bifidobacterium breve Drug: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : January 2006
Estimated Primary Completion Date : August 2008
Estimated Study Completion Date : September 2008

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Adequate relief and SIBSQ [ Time Frame: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment ]

Secondary Outcome Measures :
  1. Psychometric test, bowel gas, blood, and feces. [ Time Frame: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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

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 Posted: August 20, 2008    Key Record Dates
Last Update Posted: August 20, 2008
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