An observational study in Glucose-Galactose Malabsorption, Enteropathy and Malnutrition, Child, sponsored by University of Virginia. Status unknown at 9 sites in 8 countries. Open to participants aged 12 Months to 15 Months. Per ClinicalTrials.gov, last updated 2021-10-06.
Sponsored by University of Virginia · Observational
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.
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.
260 studies on the registry are indexed under Intestinal Diseases; 53 are open to participants now.
This study's planned enrollment of 600 is above the median of 236 across 74 observational studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Because of exigent test requirements enrollment will be restricted to convenience samples from populations near centers of excellence in nutritional studies in Dhaka, Bangladesh (the International Centre for Diarrhoeal Disease Research); Bangalore, India (St. John's Research Institute, St. John's National Academy of Health Sciences); Kingston, Jamaica (The Tropical Metabolism Research Unit of the Caribbean Institute for Health Research, University of West Indies); Kakamega, Kenya (Masinde Muliro University of Science and Technology); Iquitos, Peru44 (Asociación Benefica PRISMA and the University of Virginia); and Ndola, Zambia (Tropical Disease Research Centre). These sites represent a range of epidemiologic contexts which will enhance the cross-context applicability of study results.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Comparison of SBT to Lactulose rhamnose (LR) test-% dose 90 min
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)
Time frame: 6 months after enrollment is completed
Comparison of SBT to Lactulose rhamnose (LR) test- time to 50% recovery
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)
Time frame: 6 months after enrollment is completed
Correlation of SBT (% recovery at 90 minutes) to Lactulose rhamnose (LR) test-Lactulose recovery
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
Time frame: 6 months after enrollment is completed
Correlation of SBT (time to 50% recovery) to Lactulose rhamnose (LR) test-Lactulose recovery
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
Time frame: 6 months after enrollment is completed
Correlation of SBT (% dose recovered at 09 minutes) to Lactulose rhamnose (LR) test-Mannitol recovery
The 13C-SBT (cumulative percent of dose of 13C recovered at 90 minutes post administration) will be compared to percent mannitol recovery
Time frame: 6 months after enrollment is completed
Correlation of SBT (time to recovery of 50% of dose) to Lactulose rhamnose (LR) test-Mannitol recovery
The 13C-SBT (time to 50% area under the curve 13C tracer, expressed in minutes) will be compared to percent mannitol recovery
Time frame: 6 months after enrollment is completed
Characterize the relationship between SBT (% of dose recovered at 90 min) and baseline childhood anthropometrics (attained length)
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)
Time frame: 6 months after enrollment is completed
Characterize the relationship between SBT (time to recovery of 50% of dose) and baseline childhood anthropometrics (attained length)
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)
Time frame: 6 months after enrollment is completed
Characterize the relationship between SBT and childhood anthropometrics (attained weight)
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)
Time frame: 6 months after enrollment is completed
Characterize the relationship between SBT and childhood anthropometrics (attained weight for height)
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)
Time frame: 6 months after enrollment is completed
Characterize the relationship between SBT (time to 50% recovery of 13C) and childhood linear growth, 3 months
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
Time frame: 6 months after enrollment is completed
Characterize the relationship between SBT and childhood linear growth, 6 months
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
Time frame: 6 months after enrollment is completed
Characterize the relationship between SBT (% dose recovered at 90 min)and childhood linear growth, 3 months
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
Time frame: 6 months after enrollment is completed
Characterize the relationship between SBT and childhood linear growth
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
Time frame: 6 months after enrollment is completed
Assess the relationship between the 13C-SBT (% recovery 90min) and fecal myeloperoxidase
Compare fecal myeloperoxidase concentration (ng/mL) with 13SBT (% of cumulative dose recovered at 90 minutes, expressed as %)
Time frame: Six months from the enrollment of the last subject
Assess the relationship between SBT ( time to recovery of 50% of the 13C-tracer) and fecal myeloperoxidase
Compare fecal myeloperoxidase concentration (ng/mL) with 13SBT (time to recovery of 50% of the administered 13C tracer, measured in minutes)
Time frame: Six months from the enrollment of the last subject
Assess the relationship between the 13C-SBT (% recovery 90 min) and serum fatty acid binding protein
Compare serum fatty acid binding protein concentration (ng/mL), with 13SBT as assessed by % of administered dose recovered at 90 minutes
Time frame: Six months from the enrollment of the last subject
Assess the relationship between the 13C-SBT (time to 50% recovery) and serum fatty acid binding protein concentration
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.
Time frame: Six months from the enrollment of the last subject
Assess the relationship between the 13C-SBT (time to 50% recovery) and kynurenine tryptophan ratio
Compare time to recovery of 50% of 13C probe of SBT with kynurenine tryptophan ratio (molar ratio of KT multiplied by 1000)
Time frame: Six months from the enrollment of the last subject
Assess the relationship between the 13C-SBT (% recovery at 90 minutes) and kynurenine tryptophan ratio,
Compare 13C SBT as measured by % recovery of 13C probe at 90 minutes with kynurenine tryptophan ratio
Time frame: Six months from the enrollment of the last subject
Assess the relationship between the 13C-SBT as assessed by percent of 13C tracer recovered in at 90 minutes and fecal alpha-antitrypsin concentration
Compare 13CSBT as measured by the percent of tracer recovered at 90 minutes with fecal anti-trypsin concentration (mg/g)
Time frame: Six months from the enrollment of the last subject
Assess the relationship between the 13C-SBT as measured by the time to 50% recovery of 13C and fecal alpha-antitrypsin
Compare 13C SBT as measured by the time to 50% recovery of 13C with fecal anti-trypsin concentration (mg/g)
Time frame: Six months from the enrollment of the last subject
Reproducibility of the 13C-SBT test , percent of dose recovered in first 90 minutes
We will assess the coefficient of variation and correlation coefficient between repeated cumulative percent of dose recovered at 90 minutes post administration on separate SBT tests administered one week apart done on the same child (Peru site only).
Time frame: Six months from the enrollment of the last subject
Reproducibility of the 13C-SBT test, time to 50% area under the curve of 13C tracer, expressed in minutes
We will assess the coefficient of variation and correlation coefficient between repeated SBT tests 7 days apart as assessed by the time to 50% area under the curve of 13C tracer, expressed in minutes from the same child (Peru site only).
Time frame: Six months from the enrollment of the last subject
Epidemiologic factors that influence 13C-SBT measure, percent of dose recovered at 90 minutes
Determine if significant associations exist between 13C-SBT measured as cumulative percent of dose recovered at 90 minutes post administration and the WAMI index.The WAMI index is a previously validated composite index of environmental variables to create a index that expresses the socioeconomic and physical environment in diverse geographical contexts (PMID 24656134)
Time frame: Six months from the enrollment of the last subject
Epidemiologic factors that influence 13C-SBT measure, time to 50% AUC recovered
Determine if significant associations exist between 13C-SBT measured as the time to recovery of 50% of the administered tracer and the WAMI index. The WAMI index is a previously validated composite index of environmental variables to create a index that expresses the socioeconomic and physical environment in diverse geographical contexts ((PMID 24656134).
Time frame: Six months from the enrollment of the last subject
Plan to share: No
Started Sep 2019 (actual). Primary completion is estimated for Jul 2022, 34 months after the start.
Of 35 observational studies under Intestinal Diseases, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 102. This study's planned 34 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.