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

This study has been completed.
Sponsor:
Collaborator:
VSL Pharmaceuticals
Information provided by (Responsible Party):
Julia Bracken, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00944736
First received: July 22, 2009
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Dietary Supplement: VSL#3
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in Remission

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Intestinal Permeability - measured by Sugar Absorption Test [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: July 2009
Study Completion Date: July 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VSL#3 Dietary Supplement: VSL#3
1 packet BID
Placebo Comparator: Placebo Dietary Supplement: Placebo
1 inactive packet BID

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.

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944736

Locations
United States, Missouri
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
VSL Pharmaceuticals
Investigators
Principal Investigator: Julia M Bracken, MD Children's Mercy Hospital
  More Information

No publications provided

Responsible Party: Julia Bracken, Assistant Professor of Medicine, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00944736     History of Changes
Other Study ID Numbers: 09 06-115
Study First Received: July 22, 2009
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Crohn's Disease
Pediatric
VSL#3
Permeability
Probiotic
Zonulin

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 16, 2014