Effect of Bifidobacterium on Irritable Bowel Syndrome | NCT00737841

Studies
Effect of Bifidobacterium on Irritable Bowel Syndrome

NCT00737841

Sponsor

Tohoku University

Status

Unknown status

Last Update Posted

Aug 20, 2008Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome

Interventions

Bifidobacterium breve
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Aug 2008Estimated

Completion Date

Sep 2008Estimated

First Submitted Date

Aug 18, 2008

First Submission Date that Met QC Criteria

Aug 19, 2008

First Posted Date

Aug 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2008

Last Update Posted Date

Aug 20, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Bifidobacterium breve	Drug: Bifidobacterium breve
B	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bifidobacterium breve	Drug	1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adequate relief and SIBSQ		2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment

Secondary Outcomes

Measure	Description	Time Frame
Psychometric test, bowel gas, blood, and feces.		2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of IBS with Rome II definition

Exclusion Criteria:

Diagnosis of serious diseases (both physically and mentally)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shin Fukudo, MD, PhD	Contact	+81-22-717-8214		sfukudo@mail.tains.tohoku.ac.jp
Machiko Watabe	Contact	+81-22-717-8162		wmachiko@mail.tains.tohoku.ac.jp

Overall Officials

Name	Affiliation	Role
Shin Fukudo, MD, PhD	Tohoku University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tohoku University Graduate School of Medicine	Recruiting	Sendai	Miyagi	980-8575	Japan

Type	Date	Date Unknown
Release	Oct 7, 2009
Reset	Nov 9, 2009

Submission Tracking

Estimated Results First Submitted Date

Oct 7, 2009

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 7, 2009			Nov 9, 2009

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided