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临床试验/NCT03189849
NCT03189849已完成不适用

Farms, Animals and Adolescents: Reinforcing the Microbiome

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年5月10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
11
试验地点
1
主要终点
Change in microbiota beta diversity from baseline to immediately post-camp.

研究概览

简要总结

This study will be an observational study of children who attend summer camp at the Heartland Farm Sanctuary (HFS). The investigators are exploring whether time-limited exposure to a traditional farming environment will improve children's overall health and general well-being.

详细描述

The overarching hypothesis for this study is that urban children exposed on a time-limited basis to a traditional farming environment will show increased beneficial bacteria in the gut microbiome and enhanced emotional well-being. Secondary hypotheses are that 1) increased presence of farm-derived immunoregulatory micro-organisms in the nose (indicating exposure) will be associated with measures of emotional well-being and prosocial behavior. To test these hypotheses, 40 urban children ages 7-13 years will be studied prior to and following a 1, 2, or 3-week camp experience at the Heartland Farm Sanctuary summer camp program in Verona, WI. Assessments for behavior (via questionnaires), gut microbiota composition and function (via stool) and presence in the body of farm-derived immunoregulatory micro-organisms (via nasal swab) will be assessed at baseline (2 weeks before the start of camp and the weekend before camp starts), immediately following the child's 1, 2, or 3-week camp experience and at 1 month following completion of the camp experience. Importantly, this assessment schedule will allow the investigators to assess the longevity of any observed physical or behavioral changes induced by exposure to the farming environment.

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
7 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in microbiota beta diversity from baseline to immediately post-camp.

时间窗: Immediately post-camp

Change in the mean scores in the Youth PSC from baseline to immediately post camp.

时间窗: Immediately post camp

Change in the mean scores in the WHO-5 from baseline to immediately post camp.

时间窗: Immediately post camp

Change in the mean scores in the EmQue-CA from baseline to immediately post camp.

时间窗: Immediately post camp

Change in microbiota alpha diversity from baseline to immediately post-camp.

时间窗: Immediately post-camp

Change in the mean scores in the PSC-35 from baseline to immediately post camp.

时间窗: Immediately post camp

次要结局

  • Change in the mean scores in the Youth PSC from baseline to month 1.(1 month post-camp)
  • Change in microbiota alpha diversity from baseline to month 1.(1 month post-camp)
  • Change in the mean scores in the WHO-5 from baseline to month 1.(1 month post-camp)
  • Change in the mean scores in the PSC-35 from baseline to month 1.(1 month post-camp)
  • Change in the mean scores in the EmQue-CA from baseline to month 1.(1 month post-camp)
  • Change in microbiota beta diversity from baseline to month 1.(1 month post-camp)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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