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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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

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Environmental Enteric Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The 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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm with IAA supplemntation

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

Group Type EXPERIMENTAL

Indispensable amino acids supplemntation

Intervention Type DIETARY_SUPPLEMENT

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

Arm without IAA supplementation

18-36 months-aged children will receive only milk

Group Type EXPERIMENTAL

Without Indispensable amino acids supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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IAA supplemntation

Eligibility Criteria

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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

Minimum Eligible Age

18 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No