{
  "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).",
  "authors": [
    {
      "affiliations": [
        "Department of Biostatistics and Epidemiology, School of Public Health, Rutgers The State University of New Jersey, Piscataway, New Jersey, USA",
        "Rutgers Global Health Institute, Rutgers The State University of New Jersey, New Brunswick, New Jersey, USA"
      ],
      "name": "Gwenyth O Lee"
    },
    {
      "affiliations": [
        "Nutritional and Health Related Environmental Studies Section, Division of Human Health, International Atomic Energy Agency, Vienna, Austria"
      ],
      "name": "Victor Owino"
    },
    {
      "affiliations": [
        "Department of Science and Technology-Food and Nutrition Research Institute, Taguig City, Philippines"
      ],
      "name": "Amster Fei P Baquiran"
    },
    {
      "affiliations": [
        "Division of Nutrition, St John’s Research Institute, St John’s National Academy of Health Sciences (a Unit of CBCI Society for Medical Education), Bangalore, Karnataka, India"
      ],
      "name": "Roshini M Pasanna"
    },
    {
      "affiliations": [
        "Radiological and Medical Sciences Institute, Ghana Atomic Energy Commission, Kwabenya-Accra, Ghana"
      ],
      "name": "Seyram Elom Achoribo"
    },
    {
      "affiliations": [
        "Nutrition Gastroenterology Metabolic Disease (NUTGAMED) research structure, Mohammed V University in Rabat, Rabat, Morocco"
      ],
      "name": "Toufik Meskini"
    },
    {
      "affiliations": [
        "Tropical Gastroenterology and Nutrition Group, Department of Medicine, University of Zambia School of Medicine, Lusaka, Zambia"
      ],
      "name": "Beatrice Amadi"
    },
    {
      "affiliations": [
        "Department of Nutrition and Dietetics, School of Global and Public Health, Kamuzu University of Health Sciences, Blantyre, Malawi"
      ],
      "name": "Kenneth Mphatso Maleta"
    },
    {
      "affiliations": [
        "INRAE, UMR PNCA, Université Paris-Saclay AgroParisTech, Paris, France"
      ],
      "name": "Claire Gaudichon"
    },
    {
      "affiliations": [
        "Department of Science and Technology-Food and Nutrition Research Institute, Taguig City, Philippines"
      ],
      "name": "Michael E Serafico"
    },
    {
      "affiliations": [
        "Department of Pediatric Surgery, St John's Medical College Hospital, St John's National Academy of Health Sciences (A unit of CBCI Society for Medical Education), Bangalore, Karnataka, India"
      ],
      "name": "Shalini Hegde"
    },
    {
      "affiliations": [
        "Department of Science and Technology-Food and Nutrition Research Institute, Taguig City, Philippines"
      ],
      "name": "Carl Vincent D Cabanilla"
    },
    {
      "affiliations": [
        "Division of Nutrition, St John’s Research Institute, St John’s National Academy of Health Sciences (a Unit of CBCI Society for Medical Education), Bangalore, Karnataka, India"
      ],
      "name": "Sarita Devi"
    },
    {
      "affiliations": [
        "Life Sciences Division, National Centre of Energy, Nuclear Sciences and Technics (CNESTEN), Rabat, Morocco"
      ],
      "name": "Mohammed El Mzibri"
    },
    {
      "affiliations": [
        "Department of Epidemiology, University of Michigan, Ann Arbor, Michigan, USA"
      ],
      "name": "Andrew F Brouwer"
    },
    {
      "affiliations": [
        "Division of Nutrition, St John’s Research Institute, St John’s National Academy of Health Sciences (a Unit of CBCI Society for Medical Education), Bangalore, Karnataka, India"
      ],
      "name": "Anura V Kurpad"
    },
    {
      "affiliations": [
        "Tropical Gastroenterology and Nutrition Group, Department of Medicine, University of Zambia School of Medicine, Lusaka, Zambia",
        "Blizard Institute, Barts and The London School of Medicine, Queen Mary University of London, London, UK"
      ],
      "name": "Paul Kelly"
    },
    {
      "affiliations": [
        "Scottish Universities Environmental Research Centre (SUERC), University of Glasgow, Glasgow, UK"
      ],
      "name": "Douglas Morrison"
    }
  ],
  "title": "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",
  "uid": "8101cfa7-02d1-577a-a3b8-4fd3f896a551"
}