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

This study has been terminated.
(Lack of enrollment)
Information provided by (Responsible Party):
Anthony Lembo, Beth Israel Deaconess Medical Center Identifier:
First received: September 13, 2005
Last updated: March 2, 2017
Last verified: March 2017
To evaluate the effects of VSL#3 on symptoms associated with diarrhea predominant IBS

Condition Intervention
Drug: VSL#3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
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:

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
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • IBS diarrhea

Exclusion Criteria:

  • < 18 years of age
  • Pregnancy/breast feeding
  • concomitant medications to reduce bowel function
  Contacts and Locations
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Please refer to this study by its identifier: NCT00179582

United States, Massachusetts
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Principal Investigator: Anthony Lembo, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Anthony Lembo, Associate Professor of Medicine, Beth Israel Deaconess Medical Center Identifier: NCT00179582     History of Changes
Other Study ID Numbers: 2004P000001
Study First Received: September 13, 2005
Last Updated: March 2, 2017

Keywords provided by Beth Israel Deaconess Medical Center:
Functional bowel disorder

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on May 22, 2017