Crohn's Disease Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | July 2013 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 11 Years to 17 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Children's Mercy Hospital | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City | VSL Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intestinal Permeability - measured by Sugar Absorption Test | 3 months | No |
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