drugset / Trial / NCT01841099

Mesalamine in Environmental Enteropathy

NCT01841099

Phase 1/2 Completed 44 enrolled Kelsey Jones Imperial College London · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

Undernutrition is one of the most important health issues in Kenya. Children who are chronically undernourished do not reach their full potential and are at increased risk of infectious disease. Stunting occurs in a third of Kenyan children and has severe and long-term consequences in terms of health, development, and poverty. Several studies have shown that stunting is frequently associated with subclinical inflammation of the bowel, a condition referred to as Environmental Enteropathy (EE), previously known as 'tropical sprue' or 'tropical enteropathy'. EE is clinically similar to childhood inflammatory bowel diseases (IBD), including Crohn's disease. The treatment of IBD routinely involves provision of gut immunomodulatory agents, but this approach has never been tried in EE. This proposal outlines a pilot double-blind randomised placebo-controlled trial of mesalamine (also called mesalazine - the safest immunomodulator used in IBD with least systemic activity) in treatment of severely malnourished children with EE.

Timeline

Start
2013-06
Primary completion
2014-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Mesalamine Small molecule 50 mg/kg Oral