Overview

This trial is active, not recruiting.

Condition ibs
Treatment vsl#3
Sponsor Beth Israel Deaconess Medical Center
Trial size 180 participants
Trial identifier NCT00179582, 2004P-000001, VSL1

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Global improvement in IBS symptoms
time frame:

Secondary Outcomes

Measure
Frequency of bowel movements
time frame:
Changes in abdominal pain
time frame:
Changes in bloating
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - IBS diarrhea Exclusion Criteria: - < 18 years of age - Pregnancy/breast feeding - concomitant medications to reduce bowel function

Additional Information

Official title A Randomized, Multi-center, Double-blind, Placebo Controlled, Dose Ranging Study With VSL#3 in Diarrhea Predominant IBS Patients
Principal investigator Anthony Lembo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.