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临床试验/NCT02647580
NCT02647580已完成不适用

Appetite-regulating Hormones, the Gut Microbiome and the Metabolome in Children With Failure to Thrive

Lena Kirchner Brahe1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples

研究概览

简要总结

Failure to thrive (FTT) is an expression for inadequate growth in the early childhood and thus, a sign of undernutrition. This study will include children with FTT, and compare with existing data from children with normal and excessive growth.

The overall aim of this study is to explore whether 1) children who develop FTT with no organic explanation differ from healthy normal weight and overweight children in their basal level of appetite-regulating hormones and 2) if inadequate, normal and excessive growth in children can be partly predicted by variation in their gut microbiome and metabolome.

研究设计

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

入排标准

年龄范围
12 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with failure to thrive
  • Weight for height > 1.9 SD below the median by use of the WHO Child Growth Standards
  • Age between 12-36 months

排除标准

  • Inflammatory bowel disease
  • Celiac disease
  • Immunodeficiency
  • Other somatic disease that can explain the growth failure

结局指标

主要结局

Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples

时间窗: At subject enrollment

次要结局

  • Metabolome measured by urine samples(At subject enrollment)
  • Head circumference measured in centimeters(At subject enrollment)
  • Microbiota composition measured by fecal samples(At subject enrollment)
  • Body weight measured in kilograms(At subject enrollment)
  • Waist circumference measured in centimeters(At subject enrollment)
  • Metabolic markers (insulin, glucose) measured by fasting blood samples(At subject enrollment)
  • Height measured in centimeters(At subject enrollment)

研究者

发起方
Lena Kirchner Brahe
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lena Kirchner Brahe

Assistant professor, PhD

University of Copenhagen

研究点 (1)

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