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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00179582
First received: September 13, 2005
Last updated: May 26, 2010
Last verified: May 2010
  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
Endpoint Classification: Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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:
ClinicalTrials.gov Identifier: NCT00179582     History of Changes
Other Study ID Numbers: 2004P-000001, VSL1
Study First Received: September 13, 2005
Last Updated: May 26, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014