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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04109352




Registration number
NCT04109352
Ethics application status
Date submitted
20/07/2019
Date registered
30/09/2019
Date last updated
6/10/2021

Titles & IDs
Public title
Labelled Carbon Sucrose Breath Test (13C-SBT) as a Marker of Environmental Enteropathy
Scientific title
Validation and Field-applicability of a 13C-Sucrose Breath Test to Assess Carbohydrate Uptake and Utilization in Environmental Enteropathy Among Children in Resource Poor Settings: A Multi-site Prospective Study
Secondary ID [1] 0 0
CE0783.19
Universal Trial Number (UTN)
Trial acronym
SBT4EE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glucose-Galactose Malabsorption 0 0
Enteropathy 0 0
Malnutrition, Child 0 0
Intestinal Permeability 0 0
Linear Growth Failure 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison of SBT to Lactulose rhamnose (LR) test-% dose 90 min
Timepoint [1] 0 0
6 months after enrollment is completed
Primary outcome [2] 0 0
Comparison of SBT to Lactulose rhamnose (LR) test- time to 50% recovery
Timepoint [2] 0 0
6 months after enrollment is completed
Primary outcome [3] 0 0
Correlation of SBT (% recovery at 90 minutes) to Lactulose rhamnose (LR) test-Lactulose recovery
Timepoint [3] 0 0
6 months after enrollment is completed
Primary outcome [4] 0 0
Correlation of SBT (time to 50% recovery) to Lactulose rhamnose (LR) test-Lactulose recovery
Timepoint [4] 0 0
6 months after enrollment is completed
Primary outcome [5] 0 0
Correlation of SBT (% dose recovered at 09 minutes) to Lactulose rhamnose (LR) test-Mannitol recovery
Timepoint [5] 0 0
6 months after enrollment is completed
Primary outcome [6] 0 0
Correlation of SBT (time to recovery of 50% of dose) to Lactulose rhamnose (LR) test-Mannitol recovery
Timepoint [6] 0 0
6 months after enrollment is completed
Primary outcome [7] 0 0
Characterize the relationship between SBT (% of dose recovered at 90 min) and baseline childhood anthropometrics (attained length)
Timepoint [7] 0 0
6 months after enrollment is completed
Primary outcome [8] 0 0
Characterize the relationship between SBT (time to recovery of 50% of dose) and baseline childhood anthropometrics (attained length)
Timepoint [8] 0 0
6 months after enrollment is completed
Primary outcome [9] 0 0
Characterize the relationship between SBT and childhood anthropometrics (attained weight)
Timepoint [9] 0 0
6 months after enrollment is completed
Primary outcome [10] 0 0
Characterize the relationship between SBT and childhood anthropometrics (attained weight for height)
Timepoint [10] 0 0
6 months after enrollment is completed
Primary outcome [11] 0 0
Characterize the relationship between SBT (time to 50% recovery of 13C) and childhood linear growth, 3 months
Timepoint [11] 0 0
6 months after enrollment is completed
Primary outcome [12] 0 0
Characterize the relationship between SBT and childhood linear growth, 6 months
Timepoint [12] 0 0
6 months after enrollment is completed
Primary outcome [13] 0 0
Characterize the relationship between SBT (% dose recovered at 90 min)and childhood linear growth, 3 months
Timepoint [13] 0 0
6 months after enrollment is completed
Primary outcome [14] 0 0
Characterize the relationship between SBT and childhood linear growth
Timepoint [14] 0 0
6 months after enrollment is completed
Secondary outcome [1] 0 0
Assess the relationship between the 13C-SBT (% recovery 90min) and fecal myeloperoxidase
Timepoint [1] 0 0
Six months from the enrollment of the last subject
Secondary outcome [2] 0 0
Assess the relationship between SBT ( time to recovery of 50% of the 13C-tracer) and fecal myeloperoxidase
Timepoint [2] 0 0
Six months from the enrollment of the last subject
Secondary outcome [3] 0 0
Assess the relationship between the 13C-SBT (% recovery 90 min) and serum fatty acid binding protein
Timepoint [3] 0 0
Six months from the enrollment of the last subject
Secondary outcome [4] 0 0
Assess the relationship between the 13C-SBT (time to 50% recovery) and serum fatty acid binding protein concentration
Timepoint [4] 0 0
Six months from the enrollment of the last subject
Secondary outcome [5] 0 0
Assess the relationship between the 13C-SBT (time to 50% recovery) and kynurenine tryptophan ratio
Timepoint [5] 0 0
Six months from the enrollment of the last subject
Secondary outcome [6] 0 0
Assess the relationship between the 13C-SBT (% recovery at 90 minutes) and kynurenine tryptophan ratio,
Timepoint [6] 0 0
Six months from the enrollment of the last subject
Secondary outcome [7] 0 0
Assess the relationship between the 13C-SBT as assessed by percent of 13C tracer recovered in at 90 minutes and fecal alpha-antitrypsin concentration
Timepoint [7] 0 0
Six months from the enrollment of the last subject
Secondary outcome [8] 0 0
Assess the relationship between the 13C-SBT as measured by the time to 50% recovery of 13C and fecal alpha-antitrypsin
Timepoint [8] 0 0
Six months from the enrollment of the last subject

Eligibility
Key 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.
Minimum age
12 Months
Maximum age
15 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders University - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Bangladesh
State/province [1] 0 0
Dhaka
Country [2] 0 0
India
State/province [2] 0 0
Bengaluru
Country [3] 0 0
Jamaica
State/province [3] 0 0
Kingston
Country [4] 0 0
Kenya
State/province [4] 0 0
Kakamega
Country [5] 0 0
Peru
State/province [5] 0 0
Iquitos
Country [6] 0 0
United Kingdom
State/province [6] 0 0
East Kilbride
Country [7] 0 0
Zambia
State/province [7] 0 0
Lusaka
Country [8] 0 0
Zambia
State/province [8] 0 0
Ndola

Funding & Sponsors
Primary sponsor type
Other
Name
University of Virginia
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
International Atomic Energy Agency
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Flinders University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
International Centre for Diarrhoeal Disease Research, Bangladesh
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
St. John's Research Institute
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
The University of The West Indies
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Mmust Masinde Muliro University of Science and Technology
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Asociacion Benefica Prisma
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Scottish Universities Environmental Research Centre
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
University of Michigan
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Government body
Name [10] 0 0
Tropical Diseases Research Centre, Zambia
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Gastroenterology Services, Ltd.
Address [11] 0 0
Country [11] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT04109352
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Victor Owino, PhD
Address 0 0
International Atomic Energy Agency
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Margaret N Kosek, MD
Address 0 0
Country 0 0
Phone 0 0
434-243-9552
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04109352