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临床试验/NCT06578351
NCT06578351已完成不适用

TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)

Danone Asia Pacific Holdings Pte, Ltd.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月8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
60
试验地点
1
主要终点
user experience using a survey form to evaluate user's perspective on using OneBiome report to monitor microbiome and eating pattern

研究概览

简要总结

TRacking Atopic dermatitis Infants and their Microbiome: A study to primarily assess the user experience of parents of infants with early onset eczema and parents of healthy infants on OneBiome real-world evidence research platform.

详细描述

Parents of healthy infants as well as parents of infants with early onset eczema:

  • user experience of reading and understanding the microbiome and eating pattern analysis reports
  • user experience of using and understanding the microbiome and nutrition platforms that allow parents to monitor microbiome and eating patterns of their child overtime

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Infants diagnosed with early onset eczema (<12 months of age) and healthy infants (<6 months of age, before weaning).
  • Parents of children should have access to the internet and a smartphone or tablet to access the OneBiome mobile friendly website.
  • Parents of children should be able to comprehend the content in the OneBiome mobile friendly website and complete the questionnaires in English.
  • Parents of children should stay in Singapore and remain contactable.

排除标准

  • Children born prematurely.
  • Children with a chronic illness.
  • Children with congenital malformations, surgeries in the neonatal period or genetic syndromes.
  • Incapability of the parents of children to access OneBiome mobile friendly website and complete the questionnaires in English.
  • Any other family member is enrolled in the study.
  • Incapability of the 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.

研究组 & 干预措施

Healthy Infants

Healthy. no atopic dermatitis

Infants with early onset of eczema

diagnosed with early onset eczema

结局指标

主要结局

user experience using a survey form to evaluate user's perspective on using OneBiome report to monitor microbiome and eating pattern

时间窗: Up to age 18 months

User experience of using and understanding the microbiome and nutrition platforms that allow parents to monitor microbiome and eating patterns of their child overtime.

user experience using a survey form to evaluate user's understanding of OneBiome report

时间窗: Up to age 18 months

user experience of reading and understanding the microbiome and eating pattern analysis reports.

次要结局

  • HCP reported applicability of OneBiome concept by parents via a survey form(Up to age 18 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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