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临床试验/NCT06285630
NCT06285630Enrolling By Invitation不适用

The Development and Health of the Intestinal Flora During the First Year of Life

Alba Health AB1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
300
试验地点
1
主要终点
Microbiome composition of infants in variable age ranges

研究概览

简要总结

In this research study (PREVENT 1), Alba Health, in collaboration with academic institutions (Uppsala University, COPSAC and University of Antwerp) is investigating the association between the developing gut microbiota (collection of microbes present in the human gut) in the first year of life and lifestyle, wellbeing and health in a Swedish population. The study is the first of its kind in a Swedish population to collect and associate microbiome composition to an extensive family history and health questionnaire, stool colour and crying type, building on learnings from previous studies performed in other countries, such as the HELMI and COPSAC studies (HELMI - Finnish Health and Early Life Microbiota cohort from the University of Helsinki in Finland; COPSAC - Copenhagen Prospective Studies on Asthma in Childhood in Denmark).

The PREVENT 1 study is an observational research study led by Alba Health involving 300 families in Sweden with children between 0 and 12 months of age at the time of the study's start. After providing informed consent, the participating families will be asked to provide three stool samples from their child (the sample collection is not invasive and does not cause discomfort) and will be asked to answer questionnaires on lifestyle, well-being and family health. The participating families will not be asked to change their lifestyle beyond sample and data collection.

From the collected stool samples, we will extract microbial DNA and subject this to deep metagenomic sequence analysis. The study will only analyze microbial DNA, any human related material will be discarded. The stool samples will be destroyed within one month of sequencing (maximum 3 months from collection). The data will be stored according to GDPR and Swedish law, with informed consent in Sweden and with appropriate security measures. All research will be carried out in Sweden.

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
3 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy infants, no preterm and not undergoing antibiotic treatment

排除标准

  • Preterm delivered infants or infants undergoing antibiotic treatment

结局指标

主要结局

Microbiome composition of infants in variable age ranges

时间窗: 3 times points with 3 months in between time points

How the microbiome changes according to age

次要结局

  • Is the composition associated with and gastrointestinal issues(3 times points with 3 months in between time points)

研究者

发起方
Alba Health AB
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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