Malnutrition Clinical Trial
Official title:
Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE)
Several host factors underlie the pathogenesis of the reciprocal cycle of childhood diarrhea
and undernutrition in developing countries. These include intestinal inflammation, mucosal
damage, and alterations in intestinal barrier function that lead to malabsorption, growth
failure, and heightened susceptibility to recurrent and prolonged episodes of diarrhea.
Recent studies from Northeast Brazil demonstrate the benefits of a novel
alanyl-glutamine-based oral rehydration and nutrition therapy (Ala-Gln ORNT) in speeding the
recovery of damaged intestinal barrier function in cell culture, animal models, patients
with AIDS, and underweight children.
Oral supplementation with Alanyl-Glutamine (Ala-Gln; 24g a day for 10 days) improves
short-term gut integrity and weight velocity 4 months after therapy in a group of
undernourished children from Northeast Brazil. Intervention and Mechanisms of
Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE) is a study designed
to answer the following questions: 1) What is the lowest dose of Ala-Gln that improves
intestinal barrier function, intestinal inflammation, and nutritional status in children at
risk of underweight, wasting, or stunting? 2) What are the mechanisms by which Ala-Gln
exerts these benefits?
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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