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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-36
SponsorMorocco's National Centre for Energy, Sciences and Nuclear Techniques

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stunting estimated at least - 2 z score height -for-age

mucosal inflammation,

villous blunting

altered barrier integrity

Disqualifiers

Celiac disease

Presence of anti-tissue transglutaminase antibodies.

Primary immunodeficiency disorders

Inflammatory bowel disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Arm with IAA supplemntationExperimental treatment 1 intervention
Group B: Arm without IAA supplementationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
The procedure involves assessing gut permeability at enrolment and again after 28 days of IAA supplementation.
2

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

CCTD, Centre Hospitalier Ibn Sina,Morocco

Collaborator

AgroParisTech

Collaborator

This trial is not recruiting at the moment. You can still explore other options: