Status:
COMPLETED
Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's Disease
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborating Sponsors:
VSL Pharmaceuticals
Conditions:
Crohn's Disease
Eligibility:
All Genders
11-17 years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00944736
Start Date
July 1 2009
End Date
July 1 2013
Last Update
March 10 2014
Active Locations (1)
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1
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108