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

NCT ID: NCT04109352

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

All children will be recruited and enrolled through convenience sampling, either at the community level (if the study site has previously censused the community) or through child clinic visits.

Exclusion Criteria

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

12 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Atomic Energy Agency

OTHER_GOV

Sponsor Role collaborator

Flinders University

OTHER

Sponsor Role collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role collaborator

St. John's Research Institute

OTHER

Sponsor Role collaborator

The University of The West Indies

OTHER

Sponsor Role collaborator

Mmust Masinde Muliro University of Science and Technology

UNKNOWN

Sponsor Role collaborator

Asociacion Benefica Prisma

OTHER

Sponsor Role collaborator

Scottish Universities Environmental Research Centre

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

Tropical Diseases Research Centre, Zambia

OTHER_GOV

Sponsor Role collaborator

Gastroenterology Services, Ltd.

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Margaret Kosek, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victor Owino, PhD

Role: STUDY_CHAIR

International Atomic Energy Agency

Locations

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Flinders University

Adelaide, , Australia

Site Status RECRUITING

Nutrition and Clincial Services Division, icddr, b

Dhaka, , Bangladesh

Site Status RECRUITING

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

Bengaluru, , India

Site Status RECRUITING

Tropical Metabolism Research Unit, University of West Indies

Kingston, , Jamaica

Site Status NOT_YET_RECRUITING

Masinde Muliro University of Science and Technology

Kakamega, , Kenya

Site Status RECRUITING

Investigaciones Biomedicas, Asociacion Benefica PRISMA

Iquitos, , Peru

Site Status COMPLETED

Scottish Universities Environmental Research Centre

East Kilbride, , United Kingdom

Site Status RECRUITING

Tropical Gastroenterology & Nutrition Ltd

Lusaka, , Zambia

Site Status NOT_YET_RECRUITING

Tropical Diseases Research Centre

Ndola, , Zambia

Site Status NOT_YET_RECRUITING

Countries

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Australia Bangladesh India Jamaica Kenya Peru United Kingdom Zambia

Central Contacts

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Margaret N Kosek, MD

Role: CONTACT

[email protected]
434-243-9552

Victor Owino, PhD

Role: CONTACT

[email protected]

Facility Contacts

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Roger Yazbek, PhD

Role: primary

[email protected]

Sayeeda Huq, PhD

Role: primary

[email protected]

Nirupama Shivakumar, MBBS, DCH

Role: primary

[email protected]

Sherine White, MSc

Role: primary

[email protected]

Silvenus Konyole, PhD

Role: primary

[email protected]

Douglas Morrison, PhD

Role: primary

[email protected]

Paul Kelly, MD

Role: primary

[email protected]

Justin Chileshe, MSc

Role: primary

[email protected]

References

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Shivakumar N, Huq S, Paredes-Olortegui M, Konyole SO, Devi S, Yazbeck R, Owino VO, Brouwer AF, Kosek MN, Kelly P, Morrison DJ, Lee GO. A cross-sectional study of associations between the 13C-sucrose breath test, the lactulose rhamnose assay, and growth in children at high risk of environmental enteropathy. Am J Clin Nutr. 2024 Dec;120(6):1354-1363. doi: 10.1016/j.ajcnut.2024.10.001. Epub 2024 Oct 9.

Reference Type DERIVED
PMID: 39384142 (View on PubMed)

Lee GO, Schillinger R, Shivakumar N, Whyte S, Huq S, Ochieng Konyole S, Chileshe J, Paredes-Olortegui M, Owino V, Yazbeck R, Kosek MN, Kelly P, Morrison D. Optimisation, validation and field applicability of a 13C-sucrose breath test to assess intestinal function in environmental enteropathy among children in resource poor settings: study protocol for a prospective study in Bangladesh, India, Kenya, Jamaica, Peru and Zambia. BMJ Open. 2020 Nov 17;10(11):e035841. doi: 10.1136/bmjopen-2019-035841.

Reference Type DERIVED
PMID: 33203623 (View on PubMed)

Other Identifiers

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CE0783.19

Identifier Type: -

Identifier Source: org_study_id

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