Therapeutic Approaches to Malnutrition Enteropathy
Status:
Completed
Trial end date:
2021-04-27
Target enrollment:
Participant gender:
Summary
The TAME study will evaluate four new approaches which will be compared against the standard
care currently in use in the treatment of malnutrition enteropathy in children with severe
acute malnutrition. A high pathogen burden causes damage to the intestinal mucosa which
exacerbates nutritional impairment and leads to further susceptibility to infection and
impaired epithelial regeneration. Enteropathy is characterised by multiple epithelial
breaches, microbial translocation from gut lumen to systemic circulation and systemic
inflammation.The trial will evaluate the potential impact of four interventions (colostrum,
N-acetyl glucosamine, teduglutide, and budesonide) given for 14 days, which aim at mucosal
restoration. The trial will determine if repairing damage to the small intestinal mucosa
leads to the reduction of systemic inflammation and thus lessening the nutritional
impairment, and so if this contributes to the reduction of mortality in children.
In Zambia only, endoscopic biopsies and confocal laser endomicroscopy will be used to
evaluate response and confirm safety at a mucosal level.
Identifying an agent or agents which contribute most to mucosal healing will then ultimately
lead to further large phase 3 trial in which the agent(s) will be further evaluated.
The trial also anticipates to gain a more in depth understanding of pathophysiology and may
identify where current management strategies of treating malnutrition enteropathy in children
are failing.