Dose Ranging Study With the Probiotic Combination (VSL#3)... | NCT00179582

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

NCT00179582

Sponsor

Beth Israel Deaconess Medical Center

Status

Terminated

Last Update Posted

Feb 27, 2019Actual

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Interventions

VSL#3

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
VSL1

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of enrollment

Expanded Access Info

Start Date

Jan 2005Actual

Primary Completion Date

Jan 2006Actual

Completion Date

Jan 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2019

Last Update Posted Date

Feb 27, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anthony Lembo, Associate Professor of Medicine, Beth Israel Deaconess Medical CenterPrincipal Investigator

Lead Sponsor

Beth Israel Deaconess Medical CenterOTHER

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Name	Type	Description	Arm Group Labels	Other Names
VSL#3	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global improvement in IBS symptoms

Secondary Outcomes

Measure	Description	Time Frame
Frequency of bowel movements
Changes in abdominal pain
Changes in bloating

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IBS diarrhea

Exclusion Criteria:

< 18 years of age
Pregnancy/breast feeding
concomitant medications to reduce bowel function

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anthony Lembo, MD	Beth Israel Deaconess Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BIDMC		Boston	Massachusetts	02215	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16051399	Result	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.

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms