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The Use of VSL#3 in Irritable Bowel Syndrome in Children

NCT00932841 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-03-20

No results posted yet for this study

Summary

The goal of this study is to determine whether the oral administration of the probiotic VSL#3 under randomized, placebo-controlled conditions will improve symptoms of irritable bowel syndrome in children, safely.

Conditions

  • Irritable Bowel Syndrome

Interventions

OTHER

Placebo

One packet PO daily x 8 weeks.

DRUG

VSL#3 900 billion bacteria

One packet PO daily, x 8 weeks

DRUG

VSL#3 90 billion bacteria

One packet PO daily, x 8 weeks.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Dayton Children's Hospital

    lead OTHER

Principal Investigators

  • Sonia Michail, MD · Wright State University, Children's Medical Center of Dayton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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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 NCT00932841 on ClinicalTrials.gov