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临床试验/NCT03377777
NCT03377777已完成不适用

Development of Infants and Young Children Living in the Amazon Region of Peru: Relationship With Anemia, Chronic Malnutrition, and Gut Microbiota.

University of California, Davis0 个研究点目标入组 203 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
203
主要终点
Anemia status

研究概览

简要总结

Serum and fecal samples were collected from infants at either 6-7 m of age or 12-13 m of age. Serum and feces were analyzed locally for hemoglobin status or evidence of parasites, and standard of care was provided. Excess serum was transported to UC Davis for metabolomics analysis and the University of Hohenheim for iron status assessment and measurement of inflammatory markers. Fecal samples were transported to UC Davis for measurement of the microbiome structure and function.

详细描述

Sample collection occurred between August and November 2014. A total of 203 infants and their parents (101 at 6-7 m of age and 102 at 12-13 m of age) receiving care at the Moronacocha Health Center in Iquitos, Peru were recruited. All subjects were residents of Moronochocha, Iquitos, Loreto, outwardly healthy, and born at term with a birth weight of at least 2,500 g. Venous blood samples were collected by a lab technician at the local health center. Hemoglobin concentrations were immediately measured, and treatment given if warranted. Samples were subsequently transported to Selva Amazonica clinic, centrifuged, and serum was stored at -80 °C. Stool samples were collected by caregivers from diapers at home, taken to Selva Amazonica Clinic, and aliquoted. Fecal samples were analyzed for parasites at Selva Amazonica, and any necessary treatment was provided at the local health center. Serum and stool samples were shipped to UC Davis on dry ice, where they were stored at -80 °C until metabolomics and microbiome analyses. Serum aliquots were also shipped to the University of Hohenheim, Stuttgart, Germany for iron assessment, and measurement of inflammatory markers. All data integration and interpretation was performed at UC Davis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
6 Months 至 13 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Outwardly healthy,
  • birthweight > 2,500 g
  • term births
  • residents in Moronacocha, Iquitos, Loreto

排除标准

  • Obvious signs of illness or malnutrition
  • birthweight < 2,500 g
  • preterm birth
  • not a resident of Moronacocha, Iquitos, Loreto

结局指标

主要结局

Anemia status

时间窗: 6-7 months or 12-13 months

Anemia status \[Hb\] ≤ 110 g/L

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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