Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Children's Mercy Hospital Kansas City.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
VSL Pharmaceuticals
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00944736
First received: July 22, 2009
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  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:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Serum Zonulin [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • PDCAI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Fecal Calprotectin [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Study Completion Date: July 2012
Estimated 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 and fecal calprotecin will be monitored. Zonulin induces tight junction disassembly and has been shown to correspond to intestinal permeability in other disease groups. We will also measure serum zonulin levels to evaluate its use as a serum biomarker of intestinal permeability in Crohn's diseae.

  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

Contacts
Contact: Shawna Ricks, RN MSN 816/234-3016 sricks@cmh.edu

Locations
United States, Missouri
The Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Amy Fox, MA, CCRC     816-802-1208     arfox@cmh.edu    
Principal Investigator: Julia M Bracken, MD            
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 M Bracken, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00944736     History of Changes
Other Study ID Numbers: 09 06-115
Study First Received: July 22, 2009
Last Updated: June 21, 2011
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 June 17, 2013