Dose Ranging Study With the Probiotic Combination (VSL#3) in Diarrhea IBS

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2010 by Beth Israel Deaconess Medical Center.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT00179582

First received: September 13, 2005

Last updated: May 26, 2010

Last verified: May 2010

History of Changes

Purpose

To evaluate the effects of VSL#3 on symptoms associated with diarrhea predominant IBS

Condition	Intervention
IBS	Drug: VSL#3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Multi-center, Double-blind, Placebo Controlled, Dose Ranging Study With VSL#3 in Diarrhea Predominant IBS Patients

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

Global improvement in IBS symptoms

Secondary Outcome Measures:

Frequency of bowel movements
Changes in abdominal pain
Changes in bloating


Estimated Enrollment:	180

Detailed Description:

The study will evaluate 2 doses of VSL#3 and placebo over a 4 week period in patients presenting with diarrhea predominant IBS symptoms.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

IBS diarrhea

Exclusion Criteria:

< 18 years of age
Pregnancy/breast feeding
concomitant medications to reduce bowel function

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: NCT00179582

Locations


United States, Massachusetts
BIDMC
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators


Principal Investigator:	Anthony Lembo, MD	Beth Israel Deaconess Medical Center

More Information

Publications:

Niv E, Naftali T, Hallak R, Vaisman N. The efficacy of Lactobacillus reuteri ATCC 55730 in the treatment of patients with irritable bowel syndrome--a double blind, placebo-controlled, randomized study. Clin Nutr. 2005 Dec;24(6):925-31. Epub 2005 Jul 27.


ClinicalTrials.gov Identifier:	NCT00179582 History of Changes
Other Study ID Numbers:	2004P-000001, VSL1
Study First Received:	September 13, 2005
Last Updated:	May 26, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:


IBS Functional bowel disorder Diarrhea probiotic

ClinicalTrials.gov processed this record on March 03, 2015

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