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Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's Disease - NCT00944736-64108(Clinical Trial 303135)



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City:  Kansas City
State:  
MO
Zip Code: 64108
Conditions: Crohn's Disease
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.
Study summary: 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 will be followed. 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.
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
Study is available at: The Children's Mercy Hospital
Kansas City, MO 64108
United States

Primary Contact:
Amy Fox, MA, CCRC
Email: arfox@cmh.edu
Phone: 816-802-1208

Secondary Contact:
Shawna Ricks, RN MSN
Email: sricks@cmh.edu
Phone: 816/234-3016
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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