Use of Stable Isotopic Dilution to Assess the Bioavailability of Indispensable Amino Acids in Children With Environmental Enteropathy Dysfunction (IAA-EED)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Celiac disease
- •Presence of anti-tissue transglutaminase antibodies.
- •Primary immunodeficiency disorders
- •Inflammatory bowel disease
- •Intestinal inflammation food allergy
结局指标
主要结局
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.
时间窗: The procedure involves assessing gut permeability at enrolment and again after 28 days of 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.
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.
时间窗: The procedure involves assessing the rate of IAA bioavailability at enrolment and again 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.
次要结局
未报告次要终点
研究者
Mohammed El Mzibri
Head of the Life Sciences Division
Morocco's National Centre for Energy, Sciences and Nuclear Techniques