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Effect of Bifidobacterium on Irritable Bowel Syndrome (PBIBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Bifidobacterium breve
Placebo
Sponsored by
Tohoku University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Irritable Bowel Syndrome focused on measuring stress, brain-gut interactions, visceral perception, gastrointestinal motility, emotion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of IBS with Rome II definition

Exclusion Criteria:

  • Diagnosis of serious diseases (both physically and mentally)

Sites / Locations

  • Tohoku University Graduate School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Bifidobacterium breve

Placebo

Outcomes

Primary Outcome Measures

Adequate relief and SIBSQ

Secondary Outcome Measures

Psychometric test, bowel gas, blood, and feces.

Full Information

First Posted
August 18, 2008
Last Updated
August 19, 2008
Sponsor
Tohoku University
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1. Study Identification

Unique Protocol Identification Number
NCT00737841
Brief Title
Effect of Bifidobacterium on Irritable Bowel Syndrome
Acronym
PBIBS
Official Title
Effect of Bifidobacterium on Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
September 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tohoku University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
stress, brain-gut interactions, visceral perception, gastrointestinal motility, emotion

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Bifidobacterium breve
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Bifidobacterium breve
Intervention Description
1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1.0 g of placebo, taking orally, 3 times a day for 8 weeks.
Primary Outcome Measure Information:
Title
Adequate relief and SIBSQ
Time Frame
2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
Secondary Outcome Measure Information:
Title
Psychometric test, bowel gas, blood, and feces.
Time Frame
2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of IBS with Rome II definition Exclusion Criteria: Diagnosis of serious diseases (both physically and mentally)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shin Fukudo, MD, PhD
Phone
+81-22-717-8214
Email
sfukudo@mail.tains.tohoku.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Machiko Watabe
Phone
+81-22-717-8162
Email
wmachiko@mail.tains.tohoku.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shin Fukudo, MD, PhD
Organizational Affiliation
Tohoku University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tohoku University Graduate School of Medicine
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8575
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shin Fukudo, MD, PhD
Phone
+81-22-717-8214
Email
sfukudo@mail.tains.tohoku.ac.jp
First Name & Middle Initial & Last Name & Degree
Machiko Watabe
Phone
+81-22-717-8162
Email
wmachiko@mail.tains.tohoku.ac.jp

12. IPD Sharing Statement

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Effect of Bifidobacterium on Irritable Bowel Syndrome

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