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

Children's Mercy Hospital Kansas City

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Dietary Supplement: VSL#3; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00944736

09 06-115

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 12 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 2 patient groups, including a placebo group

VSL#3

Active Comparator group

Treatment:

Dietary Supplement: VSL#3

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo