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Safety Study of Probiotics in Adults With Irritable Bowel Syndrome

NCT00971711 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-03-08

No results posted yet for this study

Summary

Determine the safety and preliminary effectiveness of VSL#3 in adults with IBS.

Conditions

  • Irritable Bowel Syndrome

Interventions

BIOLOGICAL

Probiotic

The subjects will be randomized into either a 4 week or 8 week treatment period with the probiotic. The treatment will be open label. They will take 2 packets once daily.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of Washington

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Robert J Shulman, M.D. · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00971711 on ClinicalTrials.gov