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NCT00179582 Clinical Trial

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

IBS Clinical Trial

Official title:
A Randomized, Multi-center, Double-blind, Placebo Controlled, Dose Ranging Study With VSL#3 in Diarrhea Predominant IBS Patients

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00179582
Other study ID # 2004P000001
Secondary ID VSL1
Status Terminated
Phase N/A
First received
Last updated
Start date January 2005
Est. completion date January 2006

Study information
Verified date February 2019
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 180
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- IBS diarrhea

Exclusion Criteria:

- < 18 years of age

- Pregnancy/breast feeding

- concomitant medications to reduce bowel function

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• VSL#3

Locations
Country Name City State
United States BIDMC Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Global improvement in IBS symptoms
Secondary Frequency of bowel movements
Secondary Changes in abdominal pain
Secondary Changes in bloating
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