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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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CE0783.19
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Universal Trial Number (UTN)
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Trial acronym
SBT4EE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glucose-Galactose Malabsorption
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Enteropathy
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Malnutrition, Child
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Intestinal Permeability
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Linear Growth Failure
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Condition category
Condition code
Metabolic and Endocrine
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Other metabolic disorders
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Diet and Nutrition
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Other diet and nutrition disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Comparison of SBT to Lactulose rhamnose (LR) test-% dose 90 min
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Assessment method [1]
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The 13C-SBT (cumulative percent of dose recovered at 90 minutes post administration) will be compared to LR ratio (the ratio of the percent recovery of administered lactulose and mannitol)
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Timepoint [1]
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6 months after enrollment is completed
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Primary outcome [2]
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Comparison of SBT to Lactulose rhamnose (LR) test- time to 50% recovery
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Assessment method [2]
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The 13C-SBT (time to 50% area under the curve of 13C tracer, expressed in minutes ) will be compared to LR ratio (the ratio of the percent recovery of administered lactulose and mannitol)
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Timepoint [2]
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6 months after enrollment is completed
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Primary outcome [3]
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Correlation of SBT (% recovery at 90 minutes) to Lactulose rhamnose (LR) test-Lactulose recovery
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Assessment method [3]
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The 13C-SBT (cumulative percent of dose recovered at 90 minutes post administration) will be compared to the percent lactulose recovery at 90 minutes post administration
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Timepoint [3]
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6 months after enrollment is completed
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Primary outcome [4]
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Correlation of SBT (time to 50% recovery) to Lactulose rhamnose (LR) test-Lactulose recovery
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Assessment method [4]
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The 13C-SBT (time to 50% area under the curve 13C tracer, expressed in minutes) will be compared to the percent lactulose recovery at 90 minutes post administration
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Timepoint [4]
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6 months after enrollment is completed
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Primary outcome [5]
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Correlation of SBT (% dose recovered at 09 minutes) to Lactulose rhamnose (LR) test-Mannitol recovery
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Assessment method [5]
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The 13C-SBT (cumulative percent of dose of 13C recovered at 90 minutes post administration) will be compared to percent mannitol recovery
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Timepoint [5]
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6 months after enrollment is completed
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Primary outcome [6]
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Correlation of SBT (time to recovery of 50% of dose) to Lactulose rhamnose (LR) test-Mannitol recovery
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Assessment method [6]
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The 13C-SBT (time to 50% area under the curve 13C tracer, expressed in minutes) will be compared to percent mannitol recovery
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Timepoint [6]
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6 months after enrollment is completed
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Primary outcome [7]
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Characterize the relationship between SBT (% of dose recovered at 90 min) and baseline childhood anthropometrics (attained length)
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Assessment method [7]
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We will compare results of the SBT test expressed as cumulative percent of dose recovered at 90 minutes post administration and LAZ (length for age Z-score as defined by 2006 World Health Organization norms, cross-sectional)
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Timepoint [7]
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6 months after enrollment is completed
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Primary outcome [8]
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Characterize the relationship between SBT (time to recovery of 50% of dose) and baseline childhood anthropometrics (attained length)
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Assessment method [8]
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We will compare results of the SBT test expressed as time to 50% area under the curve 13C tracer, expressed in minutes and LAZ (length for age Z-score as defined by 2006 World Health Organization norms, cross-sectional)
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Timepoint [8]
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6 months after enrollment is completed
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Primary outcome [9]
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Characterize the relationship between SBT and childhood anthropometrics (attained weight)
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Assessment method [9]
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We will compare results of the SBT test expressed as the cumulative percent of dose recovered at 90 minutes post administration and WAZ (weight for age Z-score as defined by 2006 World Health Organization norms, cross-sectional)
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Timepoint [9]
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6 months after enrollment is completed
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Primary outcome [10]
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Characterize the relationship between SBT and childhood anthropometrics (attained weight for height)
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Assessment method [10]
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We will compare results of the SBT test expressed as time to 50% area under the curve 13C tracer, expressed in minutes and WAZ (weight for age Z-score as defined by 2006 World Health Organization norms, cross-sectional)
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Timepoint [10]
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6 months after enrollment is completed
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Primary outcome [11]
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Characterize the relationship between SBT (time to 50% recovery of 13C) and childhood linear growth, 3 months
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Assessment method [11]
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We will compare values for the 13C-SBT expressed as time to 50% area under the curve 13C tracer, expressed in minutes and change in length for age Z score (WHO 2006 reference standards) over the subsequent 3 months
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Timepoint [11]
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6 months after enrollment is completed
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Primary outcome [12]
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Characterize the relationship between SBT and childhood linear growth, 6 months
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Assessment method [12]
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We will compare values for the 13C-SBT expressed as time to 50% area under the curve 13C tracer, expressed in minutes and change in length for age Z score (WHO 2006 reference standards) over the subsequent 6 months
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Timepoint [12]
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6 months after enrollment is completed
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Primary outcome [13]
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Characterize the relationship between SBT (% dose recovered at 90 min)and childhood linear growth, 3 months
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Assessment method [13]
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We will compare the 13C-SBT tests results (cumulative percent of dose recovered at 90 minutes post administration) and change in LAZ over the subsequent 3 months
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Timepoint [13]
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6 months after enrollment is completed
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Primary outcome [14]
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Characterize the relationship between SBT and childhood linear growth
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Assessment method [14]
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We will compare the 13C-SBT tests results (cumulative percent of dose recovered at 90 minutes post administration) and change in LAZ over the subsequent 6 months
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Timepoint [14]
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6 months after enrollment is completed
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Secondary outcome [1]
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Assess the relationship between the 13C-SBT (% recovery 90min) and fecal myeloperoxidase
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Assessment method [1]
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Compare fecal myeloperoxidase concentration (ng/mL) with 13SBT (% of cumulative dose recovered at 90 minutes, expressed as %)
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Timepoint [1]
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Six months from the enrollment of the last subject
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Secondary outcome [2]
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Assess the relationship between SBT ( time to recovery of 50% of the 13C-tracer) and fecal myeloperoxidase
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Assessment method [2]
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Compare fecal myeloperoxidase concentration (ng/mL) with 13SBT (time to recovery of 50% of the administered 13C tracer, measured in minutes)
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Timepoint [2]
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Six months from the enrollment of the last subject
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Secondary outcome [3]
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Assess the relationship between the 13C-SBT (% recovery 90 min) and serum fatty acid binding protein
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Assessment method [3]
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Compare serum fatty acid binding protein concentration (ng/mL), with 13SBT as assessed by % of administered dose recovered at 90 minutes
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Timepoint [3]
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Six months from the enrollment of the last subject
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Secondary outcome [4]
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Assess the relationship between the 13C-SBT (time to 50% recovery) and serum fatty acid binding protein concentration
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Assessment method [4]
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Compare serum fatty acid binding protein concentration (ng/mL) with 13SBT as measured by the time (in minutes) to the recovery of 50% of the administered dose of 13C.
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Timepoint [4]
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Six months from the enrollment of the last subject
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Secondary outcome [5]
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Assess the relationship between the 13C-SBT (time to 50% recovery) and kynurenine tryptophan ratio
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Assessment method [5]
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Compare time to recovery of 50% of 13C probe of SBT with kynurenine tryptophan ratio (molar ratio of KT multiplied by 1000)
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Timepoint [5]
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Six months from the enrollment of the last subject
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Secondary outcome [6]
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Assess the relationship between the 13C-SBT (% recovery at 90 minutes) and kynurenine tryptophan ratio,
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Assessment method [6]
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Compare 13C SBT as measured by % recovery of 13C probe at 90 minutes with kynurenine tryptophan ratio
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Timepoint [6]
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Six months from the enrollment of the last subject
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Secondary outcome [7]
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Assess the relationship between the 13C-SBT as assessed by percent of 13C tracer recovered in at 90 minutes and fecal alpha-antitrypsin concentration
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Assessment method [7]
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Compare 13CSBT as measured by the percent of tracer recovered at 90 minutes with fecal anti-trypsin concentration (mg/g)
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Timepoint [7]
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Six months from the enrollment of the last subject
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Secondary outcome [8]
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Assess the relationship between the 13C-SBT as measured by the time to 50% recovery of 13C and fecal alpha-antitrypsin
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Assessment method [8]
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Compare 13C SBT as measured by the time to 50% recovery of 13C with fecal anti-trypsin concentration (mg/g)
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Timepoint [8]
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Six months from the enrollment of the last subject
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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.
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Minimum age
12
Months
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Maximum age
15
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Sex
Both males and females
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Can healthy volunteers participate?
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Key exclusion criteria
1. Severe acute malnutrition
2. HIV positive
3. Weight for height Z >+2
4. Known medical illness contributing to growth failure
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2022
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders University - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment outside Australia
Country [1]
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Bangladesh
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State/province [1]
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Dhaka
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Country [2]
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India
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State/province [2]
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Bengaluru
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Country [3]
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Jamaica
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State/province [3]
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Kingston
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Country [4]
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Kenya
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State/province [4]
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Kakamega
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Country [5]
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Peru
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State/province [5]
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Iquitos
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Country [6]
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United Kingdom
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State/province [6]
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East Kilbride
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Country [7]
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Zambia
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State/province [7]
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Lusaka
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Country [8]
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Zambia
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State/province [8]
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Ndola
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Virginia
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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International Atomic Energy Agency
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Flinders University
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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International Centre for Diarrhoeal Disease Research, Bangladesh
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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St. John's Research Institute
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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The University of The West Indies
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Mmust Masinde Muliro University of Science and Technology
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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Asociacion Benefica Prisma
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Address [7]
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Country [7]
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Other collaborator category [8]
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Other
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Name [8]
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Scottish Universities Environmental Research Centre
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Address [8]
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Country [8]
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Other collaborator category [9]
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Other
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Name [9]
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University of Michigan
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Address [9]
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Country [9]
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Other collaborator category [10]
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Other
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Name [10]
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Tropical Diseases Research Centre, Zambia
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Address [10]
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Country [10]
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Other collaborator category [11]
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Other
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Name [11]
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Gastroenterology Services, Ltd.
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Address [11]
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Country [11]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04109352
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Victor Owino, PhD
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Address
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International Atomic Energy Agency
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Margaret N Kosek, MD
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Address
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Country
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Phone
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434-243-9552
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04109352
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