Labelled Carbon Sucrose Breath Test (13C-SBT) as a Marker of Environmental Enteropathy

Last updated: October 5, 2021
Sponsor: University of Virginia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Weight Loss

Gastrointestinal Diseases And Disorders

Diet And Nutrition

Treatment

N/A

Clinical Study ID

NCT04109352
CE0783.19
  • Ages 12-15
  • All Genders

Study Summary

Linear growth failure, a manifestation of chronic undernutrition in early childhood, is a recalcitrant problem in resource constrained settings. The underlying causes of growth failure are multifactorial, but persistent and recurrent infection and inflammation of the gastrointestinal tract and immune activation, a condition commonly referred to as environmental enteropathy, is an important contributor. A highly enriched 13C-Sucrose Breath Test, a measure of sucrase-isomaltase activity, will be evaluated as a non-invasive biomarker of environmental enteropathy, and more specifically of intestinal brush border enzyme activity in 6 resource poor countries (Bangladesh, India, Jamaica, Kenya, Peru and Zambia) in 100 volunteers aged 12-15 months (total n=600) and evaluated relative to the lactose rhamnose test and linear and ponderal growth over a 3-6 month period following biomarker assessment. Field usability will also be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria: All children will be recruited and enrolled through convenience sampling, either at thecommunity level (if the study site has previously censused the community) or through childclinic visits.

Exclusion

Exclusion Criteria:

  1. Severe acute malnutrition
  2. HIV positive
  3. Weight for height Z >+2
  4. Known medical illness contributing to growth failure

Study Design

Total Participants: 600
Study Start date:
September 01, 2019
Estimated Completion Date:
December 31, 2022

Study Description

Environmental enteropathy is associated with linear and ponderal growth shortfalls in young children in resource constrained settings. However, the physiological alterations of intestinal function that accompany both the demonstrable evidence of inflammation and architectural changes seen in biopsies from effected children have yet to be elucidated, and this knowledge gap limits the development of effective strategies to optimally manage the condition. Furthermore, a limited number of non-invasive assays exist with which to assess the presence of environmental enteropathy in low resource settings. This study aims 1) to determine if sucrose-isomaltase enzyme is altered in children with environmental enteropathy by using a 13C-Sucrose breath test 2) to determine if the test is able to be employed in resource limited settings.

Connect with a study center

  • Flinders University

    Adelaide,
    Australia

    Active - Recruiting

  • Nutrition and Clincial Services Division, icddr, b

    Dhaka,
    Bangladesh

    Active - Recruiting

  • CBCI Society for Medical Education, St John's Research Institute

    Bengaluru,
    India

    Active - Recruiting

  • Tropical Metabolism Research Unit, University of West Indies

    Kingston,
    Jamaica

    Site Not Available

  • Masinde Muliro University of Science and Technology

    Kakamega,
    Kenya

    Active - Recruiting

  • Investigaciones Biomedicas, Asociacion Benefica PRISMA

    Iquitos,
    Peru

    Completed

  • Scottish Universities Environmental Research Centre

    East Kilbride,
    United Kingdom

    Active - Recruiting

  • Tropical Gastroenterology & Nutrition Ltd

    Lusaka,
    Zambia

    Site Not Available

  • Tropical Diseases Research Centre

    Ndola,
    Zambia

    Site Not Available

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