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
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 9
- 主要终点
- Comparison of SBT to Lactulose rhamnose (LR) test-% dose 90 min
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Severe acute malnutrition
- •HIV positive
- •Weight for height Z >+2
- •Known medical illness contributing to growth failure
结局指标
主要结局
Comparison of SBT to Lactulose rhamnose (LR) test-% dose 90 min
时间窗: 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)
Correlation of SBT (% recovery at 90 minutes) to Lactulose rhamnose (LR) test-Lactulose recovery
时间窗: 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
Characterize the relationship between SBT (% of dose recovered at 90 min) and baseline childhood anthropometrics (attained length)
时间窗: 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)
Comparison of SBT to Lactulose rhamnose (LR) test- time to 50% recovery
时间窗: 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 (% dose recovered at 09 minutes) to Lactulose rhamnose (LR) test-Mannitol recovery
时间窗: 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
Characterize the relationship between SBT and childhood anthropometrics (attained weight)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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 and childhood linear growth
时间窗: 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
Characterize the relationship between SBT (time to recovery of 50% of dose) and baseline childhood anthropometrics (attained length)
时间窗: 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 (% dose recovered at 90 min)and childhood linear growth, 3 months
时间窗: 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
Correlation of SBT (time to 50% recovery) to Lactulose rhamnose (LR) test-Lactulose recovery
时间窗: 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 (time to recovery of 50% of dose) to Lactulose rhamnose (LR) test-Mannitol recovery
时间窗: 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
次要结局
- Assess the relationship between SBT ( time to recovery of 50% of the 13C-tracer) and fecal myeloperoxidase(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(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(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(Six months from the enrollment of the last subject)
- Assess the relationship between the 13C-SBT (% recovery 90min) and fecal myeloperoxidase(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(Six months from the enrollment of the last subject)
- Assess the relationship between the 13C-SBT (time to 50% recovery) and kynurenine tryptophan ratio(Six months from the enrollment of the last subject)
- Assess the relationship between the 13C-SBT (% recovery at 90 minutes) and kynurenine tryptophan ratio,(Six months from the enrollment of the last subject)
研究者
Margaret Kosek, MD
Associate Professor
University of Virginia