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

Morocco's National Centre for Energy, Sciences and Nuclear Techniques

Status: Not yet enrolling

Conditions: Environmental Enteric Dysfunction

Treatments: Dietary Supplement: Indispensable amino acids supplemntation; Dietary Supplement: Without Indispensable amino acids supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT07256028

IAEA Research Contract 24437

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 36 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stunting estimated at least - 2 z score height -for-age
• Abnormal intestinal morphology on jejunal biopsy showing features for EED:
• mucosal inflammation,
• villous blunting
• altered barrier integrity

Exclusion criteria

• Celiac disease
• Presence of anti-tissue transglutaminase antibodies.
• Primary immunodeficiency disorders
• Inflammatory bowel disease
• Intestinal inflammation food allergy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Arm with IAA supplemntation

Experimental group

Description:

18-36-month-old children will receive daily 100 ml of milk supplemented with IAA

Treatment:

Dietary Supplement: Indispensable amino acids supplemntation

Arm without IAA supplementation

Experimental group

Description:

18-36 months-aged children will receive only milk

Treatment:

Dietary Supplement: Without Indispensable amino acids supplementation