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

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00944736

Run by

Children's Mercy Hospital Kansas City

People needed

12

Starts

2009-07-01

Expected to finish

2013-07-01

Last updated by the study team

2014-03-10

Who can join

Age: 11 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Children's Mercy Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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