The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
Summary
It is hypothesized that oral naltrexone will improve inflammation of the bowel by increasing
endogenous enkephalin levels in subjects with active Crohn's disease. This is especially
important in children who often are suffering from nutritional deprivation which retards
their growth.
The key objectives are to:
1. Evaluate the effects of low dose naltrexone in children with Crohn's Disease by using
the Pediatric Crohn's Disease Activity Index (PCDAI), plasma inflammatory markers,
weight, and pediatric quality of life survey.
2. To determine the safety and toxicity of low dose naltrexone in pediatric subjects with
active Crohn's Disease.
3. Assess the potential mechanism by which naltrexone exerts its action by measuring plasma
opioid (enkephalin and endorphin levels) and proinflammatory cytokines.
Phase:
Phase 2
Details
Lead Sponsor:
Milton S. Hershey Medical Center Penn State University