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

Официальное название

Use of Stable Isotopic Dilution to Assess the Bioavailability of Indispensable Amino Acids in Children With Environmental Enteropathy Dysfunction (IAA-EED)

Обзор

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.

Подробное описание

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

Вмешательства

• Пищевая добавка 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
• Пищевая добавка 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

Первичные конечные точки

• 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. [Срок оценки: 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. [Срок оценки: The procedure involves assessing the rate of IAA bioavailability at enrolment and again after 28 days of IAA supplementation.]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Morocco · 1 центр

• department of Pediatric Hepatology Gastroenterology and Nutrition-P III. Children's hospit — Rabat

Публикации

• 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

Идентификаторы

NCT: NCT07256028 · IAEA Research Contract 24437

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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