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

Effect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in Remission

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.

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.

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