Expired Study
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Boston, Massachusetts 02215


Purpose:

To evaluate the effects of VSL#3 on symptoms associated with diarrhea predominant IBS


Study summary:

The study will evaluate 2 doses of VSL#3 and placebo over a 4 week period in patients presenting with diarrhea predominant IBS symptoms.


Criteria:

Inclusion Criteria: - IBS diarrhea Exclusion Criteria: - < 18 years of age - Pregnancy/breast feeding - concomitant medications to reduce bowel function


Study is Available At:


Original ID:

2004P000001


NCT ID:

NCT00179582


Secondary ID:

VSL1


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Beth Israel Deaconess Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Lack of enrollment


Study Type:

Interventional


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

180


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Anthony Lembo, MD
Principal Investigator
Beth Israel Deaconess Medical Center

Study Dates

Start Date:January 2005
Completion Date:January 2006
Completion Type:Actual
Primary Completion Date:January 2006
Primary Completion Type:Actual
Verification Date:February 2019
Last Changed Date:February 26, 2019
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Changes in bloating
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Changes in abdominal pain
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Frequency of bowel movements
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Global improvement in IBS symptoms
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:VSL#3

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Beth Israel Deaconess Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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. Epub 2005 Jul 27.
PMID:16051399

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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