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

Phase 3

Completed

• Conditions: Crohn's Disease
• Interventions: Dietary Supplement: VSL#3; Dietary Supplement: Placebo

• Registration Number: NCT00944736
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief Summary

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.

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Primary Completion: 2012-07
• Study Completion: 2013-07
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VSL#3	VSL#3	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Intestinal Permeability - measured by Sugar Absorption Test	3 months

Trial Locations

Locations (1)

The Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States