NCT00179582

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

September 13, 2005

Last Update Submit

February 26, 2019

Conditions

IBS

Keywords

IBSFunctional bowel disorderDiarrheaprobiotic

Outcome Measures

Primary Outcomes (1)

  • Global improvement in IBS symptoms

Secondary Outcomes (3)

  • Frequency of bowel movements

  • Changes in abdominal pain

  • Changes in bloating

Interventions

VSL#3DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IBS diarrhea

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BIDMC

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 16051399RESULT

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anthony Lembo, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

January 1, 2005

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

US(1)