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

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ClinicalTrials.gov Identifier: NCT00179582
Recruitment Status : Terminated (Lack of enrollment)
First Posted : September 16, 2005
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Anthony Lembo, Beth Israel Deaconess Medical Center

Study Description
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Brief Summary:
To evaluate the effects of VSL#3 on symptoms associated with diarrhea predominant IBS

Condition or disease Intervention/treatment Phase
IBS Drug: VSL#3 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Double-blind, Placebo Controlled, Dose Ranging Study With VSL#3 in Diarrhea Predominant IBS Patients
Actual Study Start Date : January 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Global improvement in IBS symptoms

Secondary Outcome Measures :
  1. Frequency of bowel movements
  2. Changes in abdominal pain
  3. Changes in bloating

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Anthony Lembo, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00179582     History of Changes
Other Study ID Numbers: 2004P000001
VSL1
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017

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

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