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

NCT ID: NCT00179582

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-01-31

Brief Summary

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

Detailed Description

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

Conditions

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IBS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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VSL#3

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* IBS diarrhea

Exclusion Criteria

* \< 18 years of age
* Pregnancy/breast feeding
* concomitant medications to reduce bowel function
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Anthony Lembo

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anthony Lembo, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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BIDMC

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 16051399 (View on PubMed)

Other Identifiers

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VSL1

Identifier Type: -

Identifier Source: secondary_id

2004P000001

Identifier Type: -

Identifier Source: org_study_id

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