Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's Disease

March 6, 2014 updated by: Julia Bracken, Children's Mercy Hospital Kansas City

Effect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in Remission

The purpose of this study is to determine the effect of a probiotic formulation, VSL#3, on intestinal permeability in pediatric patients with Crohn's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Children with Crohn's disease have altered intestinal permeability. A pilot study in children showed that probiotics may decrease intestinal permeability. In this double blind, randomized controlled trial, we will observe the effect of VSL#3 on small bowel permeability using a double sugar absorption test. PCDAI was monitored, but not analyzed.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • The Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current diagnosis of small bowel or colonic Crohn's disease as defined by histological and endoscopic criteria.
  • Males or females ages 11-17 years.
  • Crohn's disease in remission as defined by a Pediatric Crohn's Disease Activity Index (PCDAI) < 10
  • Patients on maintenance doses of aminosalicylates, 6-MP and/or Azathioprine for at least 2 months.
  • Procurement of written informed consent signed by the subject's legal guardian and study investigator(s) and patient assent.

Exclusion Criteria:

  • Patients with documented intestinal stricture.
  • Patients with signs of symptoms of systemic or intestinal infection.
  • Antibiotic use the previous 1 month.
  • Probiotic use in the previous 2 months (excluding yogurt).
  • Use of the following medications; Methotrexate, Cyclosporine, Tacrolimus and Infliximab.
  • Patients with diagnosis of other co-morbid diseases such as heart disease, renal disease, immunodeficiency, diabetes, or thyroid disease.
  • Patients with indwelling catheters.
  • Patients with short bowel syndrome
  • Positive urine pregnancy test for female subjects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
1 inactive packet BID
Active Comparator: VSL#3
Dietary supplement: VSL#3
1 packet BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intestinal Permeability - measured by Sugar Absorption Test
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Collaborators

VSL Pharmaceuticals

Investigators

  • Principal Investigator: Julia M Bracken, MD, Children's Mercy Hospital Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 22, 2009

First Submitted That Met QC Criteria

July 22, 2009

First Posted (Estimate)

July 23, 2009

Study Record Updates

Last Update Posted (Estimate)

March 10, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09 06-115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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