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临床试验/NCT05847543
NCT05847543已完成不适用

A Study to Develop, Evaluate, and Validate a Tool to Infer/Predict an Estimated Microbiome Profile

Danone Asia Pacific Holdings Pte, Ltd.4 个研究点 分布在 3 个国家目标入组 440 人开始时间: 2023年3月21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
440
试验地点
4
主要终点
To collect stool data and stool samples for full microbiome analysis. To collect stool images, stool data and stool samples for full microbiome analysis

研究概览

简要总结

This is a study to collect data to build, evaluate and validate (test) a tool to infer/predict an estimated microbiome (community of microorganisms such as bacteria, fungi and viruses that exists in a particular environment) profile. The study will take place at several hospitals/clinics across Singapore, Malaysia, and Thailand.

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
0 Months 至 18 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children aged from 0 to 18 months old
  • •Parent(s) should have access to the internet and a smartphone or tablet to upload stool data and complete the study questionnaires in the OneBiome web-platform.
  • •Parent(s) should be able to comprehend the content of the study and to complete the study procedures in English.
  • •Written consent from parent.

排除标准

  • •Parent(s) incapable of completing the study questionnaires and uploading of the stool data using smart phone or tablet with internet.
  • •Children born before gestational age 37 weeks.
  • •Any other family member is enrolled in the study
  • •Incapability of parents of children to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents of children to comply with the protocol requirements.

结局指标

主要结局

To collect stool data and stool samples for full microbiome analysis. To collect stool images, stool data and stool samples for full microbiome analysis

时间窗: 7 days

To collect stool data and stool samples for full microbiome analysis. To collect stool images, stool data and stool samples for full microbiome analysis

次要结局

  • To assess the microbiome composition in the stool sample of the subject(7 days)
  • To assess the dietary pattern based on Food Frequency Questionnaire (FFQ)(7 days)
  • To explore the association between microbiome composition and known factors that influence the microbiome in early life(7 days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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