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临床试验/NCT04195425
NCT04195425招募中不适用

Influence of Breastfeeding on Gut Health in Children

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Correlation between exclusive breastfeeding and gut health based on the non-invasive measurement of fecal secretory immunoglobulin A (sIgA)

研究概览

简要总结

The aim of the study is to evaluate the impact of early nutrition on gut health in children. A prospective cohort of newborns will be recruited at birth and followed up to 4 years of age. Information on parent's nutritional habits and life style, breastfeeding duration and child's complementary feeding, will be collected. Cord blood cells and stools will be collected at birth, 6 months, 2 years and 4 years of age for implementing a biological collection. Gut health will be evaluated in children during the first four years of life based on fecal secretory immunoglobulin A (SIgA) and presence of digestive symptoms. Precise data on breastfeeding practices and their short- and medium-term effects on the health of the child, in particular and in an innovative way on gut health, will be obtained.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • For the mother:
  • Pregnant woman (>18 years old) followed at the Lille University Jeanne de Flandres Maternity
  • Woman who can speak, read and write in French
  • Single pregnancy
  • Informed consent
  • Living in the Lille area
  • For the father:
  • Men >18 years old
  • Informed consent

排除标准

  • For the mother:
  • Impossibility to participate to the study follow-up
  • Woman under guardianship or curatorship
  • Woman involved in another study inconsistent with biological samples collection
  • For the child after birth:
  • Prematurity <37 weeks
  • Impossibility to participate to the study follow-up
  • Child under judicial protection measure
  • Child involved in another study inconsistent with biological samples collection

结局指标

主要结局

Correlation between exclusive breastfeeding and gut health based on the non-invasive measurement of fecal secretory immunoglobulin A (sIgA)

时间窗: AT 4 years

次要结局

  • Correlation between gut health and the duration of exclusive breastfeeding(A 1 month, 1-2 months, 2-4 months, 4-6 months, 6 months)
  • Correlation between sIgA and child growth and gastro-intestinal disorders(At 6 months, 2 years and 4 years)
  • Correlation between the mother's feeding habits during pregnancy and the child's gut health during the first 4 years of life(At 6 months, 2 years and 4 years)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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