At a glance
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The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
In Brief
A Phase 2 clinical trial evaluating Naltrexone and Placebo, sugar pill for Crohn's Disease. Completed, enrolled 14 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day orally for 16 weeks
Placebo -Sugar pill or liquid identical to active drug in appearance and taste given by mouth at bedtime once daily