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

NCT07256028 | Not Yet Recruiting DMC

• 1 other identifier: IAEA Research Contract 24437
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Environmental Enteric Dysfunction

Keywords

Indispensable amino acids; Environmental enteric dysfunction; bioavailability; amino acids supplementatuion

Outcome Measures

Primary Outcomes (2)

• Use of the lactulose/rhamnose (LR) ratio to assess improvement in gut permeability among stunted Moroccan children aged 18-36 months after 28 days of Indispensable Amino Acids (IAA) supplementation.

  The purpose of this measure is to assess gut permeability efficiency and whether supplementation with IAA can improve it. In fact, the lactulose/rhamnose (LR) ratio or the dual-sugar test is a non-invasive test used to measure intestinal permeability. It works by orally administering of two inert sugar molecules, lactulose and rhamnose, then measuring their excretion in urine; a higher LR ratio suggests increased intestinal permeability, often indicating damage to the gut lining. This test is useful in research and clinical settings for assessing conditions that affect the small intestine.

  The procedure involves assessing gut permeability at enrolment and again after 28 days of IAA supplementation.

• Use of Dual-Stable Isotope Test (DSIT) to assess improvement of the true ileal bioavailability of IAA among stunted Moroccan children aged 18-36 months after 28 days of IAA supplementation.

  The purpose of this measure is to assess the rate of IAA bioavailability and determine whether IAA supplementation can improve it. To this end, the Dual-Stable Isotope Test (DSIT) will be used. The DSIT is a minimally invasive method for measuring the true ileal bioavailability of IAAs in humans, using a meal containing both the 2H-labeled test protein and the 13C-labeled reference protein. In this study, children will consume a test meal (milk) containing both the 2H-AA mix (1.25 mg/kg body weight) and the U-13C spirulina (10 mg/kg body weight). To carry out this technique, two blood (plasma) samples will be collected, one before the meal is administrated and the second 5hours after afterwards. A portion of the meal will be frozen at -80°C for later analysis of the two isotopes. The bioavailability of each IAA is calculated by comparing the ratio of the two isotopes in the plasma samples to their ratio in the original test meal.

  The procedure involves assessing the rate of IAA bioavailability at enrolment and again after 28 days of IAA supplementation.

Study Arms (2)

Arm with IAA supplemntation

EXPERIMENTAL

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

Dietary Supplement: Indispensable amino acids supplemntation

Arm without IAA supplementation

EXPERIMENTAL

18-36 months-aged children will receive only milk

Dietary Supplement: Without Indispensable amino acids supplementation

Interventions

Indispensable amino acids supplemntation 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 with IAA supplemntation

Without Indispensable amino acids supplementation 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

Also known as: IAA supplemntation

Arm without IAA supplementation

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Morocco's National Centre for Energy, Sciences and Nuclear Techniques: lead
• CCTD, Centre Hospitalier Ibn Sina,Morocco: collaborator
• AgroParisTech: collaborator

Study Sites (1)

department of Pediatric Hepatology Gastroenterology and Nutrition-P III. Children's hospital of Rabat - the Ibn Sina University Hospital Center

Rabat, Rabat, 10001, Morocco

Location

Study Officials

• Mohammed El Mzibri

  Centre National de l'Energie, des Sciences et des Techniques Nucléaire

  PRINCIPAL INVESTIGATOR

• Toufik Meskini, Professor

  Department of Pediatric Hepatology Gastroenterology and Nutrition-P III. Children's hospital of Rabat - the Ibn Sina University Hospital Center

  STUDY DIRECTOR

Central Study Contacts

Mohammed El Mzibri, PhD

CONTACT

+212661479124; mzibri@yahoo.com

Toufik Meskini, Pr.

CONTACT

+212661412241; t.meskini@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Life Sciences Division

Model Details: 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

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 1, 2025
• Study Start: December 10, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)