Glucose-Galactose MalabsorptionSBT4EENCT04109352
Labelled Carbon Sucrose Breath Test (13C-SBT) as a Marker of Environmental Enteropathy
An observational study of Glucose-Galactose Malabsorption and Enteropathy, run by University of Virginia at 9 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 15 months
- Conditions the study is for
- Glucose-Galactose Malabsorption, Enteropathy, Malnutrition, Child
- How many people
- 600 participants
- Where
- 9 sitesin 8 countries
- Study dates
- 1 Sep 2019to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 months
- All sexes
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Severe acute malnutrition
- HIV positive
- Weight for height Z >+2
- Known medical illness contributing to growth failure
Trial locations and contacts
9 sites in 8 countries.
Victor Owino, PhD contact
9 sites in 8 countries
Zambia2 sites, 2 recruiting
- Not yet recruiting
Tropical Gastroenterology & Nutrition Ltd
Lusaka
Paul Kelly, MD, m.p.kelly@qmul.ac.uk
- Not yet recruiting
Tropical Diseases Research Centre
Ndola
Justin Chileshe, MSc, chilesej@tdrc.org.zm
Australia1 site, 1 recruiting
- Recruiting
Flinders University
Adelaide
Roger Yazbek, PhD, roger.yazbek@flinders.edu.au
Bangladesh1 site, 1 recruiting
- Recruiting
Nutrition and Clincial Services Division, icddr, b
Dhaka
Sayeeda Huq, PhD, sayeeda@icddrb.org
India1 site, 1 recruiting
- Recruiting
CBCI Society for Medical Education, St John's Research Institute
Bengaluru
Nirupama Shivakumar, MBBS, DCH, nirupama.s@sjri.res.in
Jamaica1 site, 1 recruiting
- Not yet recruiting
Tropical Metabolism Research Unit, University of West Indies
Kingston
Sherine White, MSc, sherine.whyte@uwimona.edu.jm
Kenya1 site, 1 recruiting
- Recruiting
Masinde Muliro University of Science and Technology
Kakamega
Silvenus Konyole, PhD, konyole2000@yahoo.com
Peru1 site
- Completed
Investigaciones Biomedicas, Asociacion Benefica PRISMA
Iquitos
United Kingdom1 site, 1 recruiting
- Recruiting
Scottish Universities Environmental Research Centre
East Kilbride
Douglas Morrison, PhD, douglas.morrison@glasgow.ac.uk
About this study
Official 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
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.
Read the detailed description
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
- Glucose-Galactose Malabsorption, Enteropathy, Malnutrition, Child, Intestinal Permeability, Linear Growth Failure
- Medical subject headings
- Glucose-Galactose Malabsorption, Intestinal Diseases, Child Nutrition Disorders, Failure to Thrive
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after enrollment is completed
Secondary outcomes (8)
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 %)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: Six months from the enrollment of the last subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Sep 2019
- Primary completion1 Jul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glucose-Galactose MalabsorptionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency, Flinders University, International Centre for Diarrhoeal Disease Research, Bangladesh, St. John's Research Institute, The University of The West Indies, Mmust Masinde Muliro University of Science and Technology, Asociacion Benefica Prisma, Scottish Universities Environmental Research Centre, University of Michigan, Tropical Diseases Research Centre, Zambia, Gastroenterology Services, Ltd.
- Responsible party
- Principal investigator, Margaret Kosek, MD, University of Virginia
- Investigators
- Victor Owino, PhD, Study chair, International Atomic Energy Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109352
- Sponsor's protocol ID
- CE0783.19
- Acronym
- SBT4EE
- Status last verified
- Oct 2021
- First submitted
- 20 Jul 2019
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39384142Lee 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.
PubMed 33203623
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04109352
- Acronym / sponsor ID
- SBT4EE / CE0783.19
- Conditions
- Glucose-Galactose Malabsorption, Enteropathy, Malnutrition, Child, Intestinal Permeability, Linear Growth Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency, Flinders University, International Centre for Diarrhoeal Disease Research, Bangladesh, St. John's Research Institute, The University of The West Indies, Mmust Masinde Muliro University of Science and Technology, Asociacion Benefica Prisma, Scottish Universities Environmental Research Centre, University of Michigan, Tropical Diseases Research Centre, Zambia, Gastroenterology Services, Ltd.
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Severe acute malnutrition
- HIV positive
- Weight for height Z >+2
- Known medical illness contributing to growth failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of SBT to Lactulose rhamnose (LR) test-% dose 90 min
Time frame: 6 months after enrollment is completed
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)
Comparison of SBT to Lactulose rhamnose (LR) test- time to 50% recovery
Time frame: 6 months after enrollment is completed
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)
Correlation of SBT (% recovery at 90 minutes) to Lactulose rhamnose (LR) test-Lactulose recovery
Time frame: 6 months after enrollment is completed
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
Correlation of SBT (time to 50% recovery) to Lactulose rhamnose (LR) test-Lactulose recovery
Time frame: 6 months after enrollment is completed
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
Correlation of SBT (% dose recovered at 09 minutes) to Lactulose rhamnose (LR) test-Mannitol recovery
Time frame: 6 months after enrollment is completed
The 13C-SBT (cumulative percent of dose of 13C recovered at 90 minutes post administration) will be compared to percent mannitol recovery
Correlation of SBT (time to recovery of 50% of dose) to Lactulose rhamnose (LR) test-Mannitol recovery
Time frame: 6 months after enrollment is completed
The 13C-SBT (time to 50% area under the curve 13C tracer, expressed in minutes) will be compared to percent mannitol recovery
Characterize the relationship between SBT (% of dose recovered at 90 min) and baseline childhood anthropometrics (attained length)
Time frame: 6 months after enrollment is completed
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)
Characterize the relationship between SBT (time to recovery of 50% of dose) and baseline childhood anthropometrics (attained length)
Time frame: 6 months after enrollment is completed
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)
Characterize the relationship between SBT and childhood anthropometrics (attained weight)
Time frame: 6 months after enrollment is completed
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)
Characterize the relationship between SBT and childhood anthropometrics (attained weight for height)
Time frame: 6 months after enrollment is completed
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)
Characterize the relationship between SBT (time to 50% recovery of 13C) and childhood linear growth, 3 months
Time frame: 6 months after enrollment is completed
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
Characterize the relationship between SBT and childhood linear growth, 6 months
Time frame: 6 months after enrollment is completed
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
Characterize the relationship between SBT (% dose recovered at 90 min)and childhood linear growth, 3 months
Time frame: 6 months after enrollment is completed
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
Characterize the relationship between SBT and childhood linear growth
Time frame: 6 months after enrollment is completed
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
8 secondary outcomes
Assess the relationship between the 13C-SBT (% recovery 90min) and fecal myeloperoxidase
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
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
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
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
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,
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
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
Time frame: Six months from the enrollment of the last subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Derived from this study: PubMed 39384142Shivakumar 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.
- Derived from this study: PubMed 33203623Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Owino, PhD contact
Victor Owino, PhD study chair
International Atomic Energy Agency
9 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose-Galactose Malabsorption and Enteropathy, run by University of Virginia at 9 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Zambia, Australia, Bangladesh, India, Jamaica and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margaret N Kosek, MD (434-243-9552, mkosek@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of SBT to Lactulose rhamnose (LR) test-% dose 90 min (time frame: 6 months after enrollment is completed). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04109352, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.