NCT07256028

Indispensable Amino Acids Bioavailability in Children With Environmental Enteropathy Dysfunction (IAA-EED)

Use of Stable Isotopic Dilution to Assess the Bioavailability of Indispensable Amino Acids in Children With Environmental Enteropathy Dysfunction (IAA-EED)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Morocco's National Centre for Energy, Sciences and Nuclear Techniques · Academic / Other
• Sex: All
• Age: 18 Months – 36 Months
• Healthy volunteers: Not accepted

Summary

In Morocco, large efforts have been made to enhance nutritional status and health conditions of children. Accordingly, stunting was reduced and the prevalence of stunting have decreased from 28,6% in 1987 to 14,9% in 2011. Many factors, including improved nutrition, have influenced this decrease, and are reinforced to maintain this low prevalence of stunting. Of interest, quality diet, specifically with reference to its protein quality, has contributed to improve the nutritional status of the Moroccan population. However, infectious diseases are still important and in some areas many children are of high risk to develop EED that alter intestinal permeability and microbial translocation, and lead to systemic inflammation. During childhood, protein supply is of a great interest and indigestibility of these proteins and/or malabsorption of indispensable amino acids will affect children growth and many physiological and cognitive functions. This project was planned to assess indispensable amino acids during EED and to to assess the impact of some interventions (amino acids supplementation / medical treatment) on the nutritional status of children. This study will be carried out according to a trilogy of close collaboration between CNESTEN, Pr Claire Gaudichon from AgroParisTech (France) who will provide technical assistance and scientific accompaniment during the progress of the project, she will also participate in the data analysis, exploitation and valorization of results and the department of Pediatric Hepatology Gastroenterology and Nutrition-P III at the Children's Hospital in Rabat.

Detailed description

The investigators will conduct a randomized controlled trial to determine if indispensable amino acid (IAA) supplementation can improve intestinal barrier dysfunction in Moroccan patients aged 18-36-month-old with stunting or severe stunting. The primary endpoint will be change in gut permeability as assessed by the lactulose/rhamnose (LR) ratio, while secondary endpoint will focus on change in amino acid absorption using an isotope tracer test. IAA supplementation will be given daily for 28 days, and evaluation of the major endpoints will be at baseline and 28 days

Conditions

• Environmental Enteric Dysfunction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Indispensable amino acids supplemntation	18-36-month-old children in the intervention arm will receive milk with IAA supplementation for 28 days, while children in the control group will receive only milk for the same duration
DIETARY_SUPPLEMENT	Without Indispensable amino acids supplementation	18-36-month-old children in the intervention arm will receive milk with IAA supplementation for 28 days, while children in the control group will receive milk without IAA during the same duration

Timeline

• Start date: 2025-12-10
• Primary completion: 2026-03-31
• Completion: 2026-07-31
• First posted: 2025-12-01
• Last updated: 2025-12-01

Locations

1 site across 1 country: Morocco