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

This study has been terminated.

(Lack of enrollment)

Sponsor:

ClinicalTrials.gov Identifier:

NCT00179582

First Posted: September 16, 2005

Last Update Posted: March 6, 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 (Responsible Party):

Anthony Lembo, Beth Israel Deaconess Medical Center

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 Intervention Model: Parallel Assignment Masking: Double 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 Anthony Lembo, 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
Actual Study Start Date:	January 2005
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

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

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:

IBS diarrhea

Exclusion Criteria:

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

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): 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.


Responsible Party:	Anthony Lembo, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00179582 History of Changes
Other Study ID Numbers:	2004P000001 VSL1
First Submitted:	September 13, 2005
First Posted:	September 16, 2005
Last Update Posted:	March 6, 2017
Last Verified:	March 2017

Keywords provided by Anthony Lembo, Beth Israel Deaconess Medical Center:


IBS Functional bowel disorder Diarrhea probiotic

Additional relevant MeSH terms:


Diarrhea Signs and Symptoms, Digestive Signs and Symptoms

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