Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's Disease
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ClinicalTrials.gov Identifier: NCT00944736
Recruitment Status :
First Posted : July 23, 2009
Last Update Posted : March 10, 2014
Children's Mercy Hospital Kansas City
Information provided by (Responsible Party):
Julia Bracken, Children's Mercy Hospital Kansas City
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.
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Ages Eligible for Study:
11 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.