Peer-reviewed article
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 trials.
Gwenyth O Lee, Victor Owino, Amster Fei P Baquiran, Roshini M Pasanna, Seyram Elom Achoribo et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a protocol for coordinated randomised controlled trials across six countries testing whether daily supplementation with indispensable amino acids can improve gut function in young children with stunting who are at high risk of environmental enteropathy. Environmental enteropathy is a condition affecting the gut in children exposed to high levels of infection from poor water and sanitation, which damages the intestinal lining and prevents nutrient absorption. The study will measure changes in gut permeability and nutrient absorption after 28 days of amino acid supplementation in children aged 18-36 months. The research aims to determine if this nutritional intervention can help restore normal gut function in affected children.
Key points
- Environmental enteropathy is characterised by villus blunting, reduced nutrient absorption and microbial translocation in children with inadequate access to clean water and sanitation
- The trials will test daily indispensable amino acid supplementation for 28 days in 18-36 month old children with stunting or severe stunting
- Primary outcome is change in gut permeability measured by lactulose/rhamnose ratio
- Secondary outcomes include changes in amino acid and carbohydrate absorption using isotope tracer tests, EE biomarkers and child weight
- Coordinated trials are being conducted across Ghana, Malawi, Zambia, Morocco, India and the Philippines
Limitations
This is a protocol document describing planned trials rather than results, so it cannot tell us whether the intervention actually works or what outcomes were achieved. The effectiveness of amino acid supplementation on environmental enteropathy remains to be determined by the completed studies.
Abstract
INTRODUCTION: Environmental enteropathy (EE) is a syndrome affecting the gut characterised by villus blunting, reduced nutrient absorption and microbial translocation in children and adults experiencing a high burden of enteric infection due to inadequate access to clean water and sanitation. METHODS AND ANALYSIS: We will conduct coordinated randomised controlled trials in six countries to determine if supplementation with indispensable amino acids (IAAs) can improve intestinal barrier dysfunction in six geographically diverse populations of 18-36 months old children with stunting or severe stunting. All trials will measure the same primary outcomes while secondary outcomes will be measured on a per-trial basis using standardised protocols across the project. The primary endpoint will be change in gut permeability as assessed by the lactulose/rhamnose ratio. Secondary endpoints include changes in amino acid and carbohydrate absorption using novel, isotope tracer tests. Other prespecified outcome measures include changes in EE biomarkers and child weight. IAA supplementation will be given daily for 28 days and evaluation of the major endpoints will be at baseline and after 28 days of supplementation. ETHICS AND DISSEMINATION: Ethical approval will be obtained from the Research Ethics Committee at each participating site. Caregivers will provide written informed consent for each participant. Findings will be disseminated through peer-reviewed journals, conference presentations and face-to-face meetings with participant caregivers. TRIAL REGISTRATION NUMBER: CTRI: CTRI/2024/06/069187 (India); ClinicalTrials.gov (NCT06617130, Malawi; NCT06676215, Philippines and NCT07256028, Morocco); Ongoing (Zambia); Ongoing (Morocco); PACTR: (PACTR202311714091884, Ghana).
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Daily supplementation with indispensable amino acids for 28 days