Back to resultsDose Ranging Study With the Probiotic Combination (VSL#3) in Diarrhea IBS
Primary Purpose
IBS
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VSL#3
Sponsored by
About this trial
This is an interventional treatment trial for IBS focused on measuring IBS, Functional bowel disorder, Diarrhea, probiotic
Eligibility Criteria
Inclusion Criteria: IBS diarrhea Exclusion Criteria: < 18 years of age Pregnancy/breast feeding concomitant medications to reduce bowel function
Sites / Locations
- BIDMC
Outcomes
Primary Outcome Measures
Global improvement in IBS symptoms
Secondary Outcome Measures
Frequency of bowel movements
Changes in abdominal pain
Changes in bloating
Full Information
NCT ID
NCT00179582
First Posted
September 13, 2005
Last Updated
February 26, 2019
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00179582
Brief Title
Dose Ranging Study With the Probiotic Combination (VSL#3) in Diarrhea IBS
Official Title
A Randomized, Multi-center, Double-blind, Placebo Controlled, Dose Ranging Study With VSL#3 in Diarrhea Predominant IBS Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
January 2005 (Actual)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
5. Study Description
Brief Summary
To evaluate the effects of VSL#3 on symptoms associated with diarrhea predominant IBS
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS
Keywords
IBS, Functional bowel disorder, Diarrhea, probiotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
VSL#3
Primary Outcome Measure Information:
Title
Global improvement in IBS symptoms
Secondary Outcome Measure Information:
Title
Frequency of bowel movements
Title
Changes in abdominal pain
Title
Changes in bloating
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IBS diarrhea
Exclusion Criteria:
< 18 years of age
Pregnancy/breast feeding
concomitant medications to reduce bowel function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Lembo, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
BIDMC
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16051399
Citation
Niv E, Naftali T, Hallak R, Vaisman N. The efficacy of Lactobacillus reuteri ATCC 55730 in the treatment of patients with irritable bowel syndrome--a double blind, placebo-controlled, randomized study. Clin Nutr. 2005 Dec;24(6):925-31. doi: 10.1016/j.clnu.2005.06.001. Epub 2005 Jul 27.
Results Reference
result
Learn more about this trial
Dose Ranging Study With the Probiotic Combination (VSL#3) in Diarrhea IBS
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