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

NCT04109352 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2021-10-06

No results posted yet for this 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.

Conditions

  • Glucose-Galactose Malabsorption
  • Enteropathy
  • Malnutrition, Child
  • Intestinal Permeability
  • Linear Growth Failure

Sponsors & Collaborators

  • International Atomic Energy Agency

    collaborator OTHER_GOV
  • Flinders University

    collaborator OTHER
  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER
  • St. John's Research Institute

    collaborator OTHER
  • The University of The West Indies

    collaborator OTHER
  • Mmust Masinde Muliro University of Science and Technology

    collaborator UNKNOWN
  • Asociacion Benefica Prisma

    collaborator OTHER
  • Scottish Universities Environmental Research Centre

    collaborator OTHER
  • University of Michigan

    collaborator OTHER
  • Tropical Diseases Research Centre, Zambia

    collaborator OTHER_GOV
  • Gastroenterology Services, Ltd.

    collaborator OTHER
  • University of Virginia

    lead OTHER

Principal Investigators

  • Victor Owino, PhD · International Atomic Energy Agency

Eligibility

Min Age
12 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-07-01
Completion
2022-12-31

Countries

  • Australia
  • Bangladesh
  • India
  • Jamaica
  • Kenya
  • Peru
  • United Kingdom
  • Zambia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04109352 on ClinicalTrials.gov