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
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 - 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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