Indispensable Amino Acids Bioavailability in Children With Environmental Enteropathy Dysfunction (IAA-EED)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indispensable amino acids supplemntation, Without Indispensable amino acids supplementation.
- Who it may be relevant to
- Registry conditions: Environmental Enteric Dysfunction. Basic parameters: 18 months — 36 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Morocco
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of Stable Isotopic Dilution to Assess the Bioavailability of Indispensable Amino Acids in Children With Environmental Enteropathy Dysfunction (IAA-EED)
Overview
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
Interventions
- 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
Primary outcome measures
- 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. [Time frame: 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. [Time frame: The procedure involves assessing the rate of IAA bioavailability at enrolment and again after 28 days of IAA supplementation.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Morocco · 1 center
- department of Pediatric Hepatology Gastroenterology and Nutrition-P III. Children's hospit — Rabat
Publications
- Lee GO, Owino V, Baquiran AFP, Pasanna RM, Achoribo SE, Meskini T, Amadi B, Maleta KM, Gaudichon C, Serafico ME, Hegde S, Cabanilla CVD, Devi S, El Mzibri M, Brouwer AF, Kurpad AV, Kelly P, Morrison D. Impact of indispensable amino acid supplementation on gut function in children at high risk of environmental enteropathy: protocol for an international coordinated group of randomised controlled tri PMID 42031499
Identifiers
NCT: NCT07256028 · IAEA Research Contract 24437