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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Beth Israel Deaconess Medical Center.
Recruitment status was:  Active, not recruiting
Information provided by:
Beth Israel Deaconess Medical Center Identifier:
First received: September 13, 2005
Last updated: May 26, 2010
Last verified: May 2010
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
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
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
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 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

Publications: Identifier: NCT00179582     History of Changes
Other Study ID Numbers: 2004P-000001  VSL1 
Study First Received: September 13, 2005
Last Updated: May 26, 2010

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 February 20, 2017