Effect of VSL#3 on Intestinal Permeability in Pediatric 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 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.

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