Farms, Animals and Adolescents: Reinforcing the Microbiome

Completed

• Conditions: Healthy

• Registration Number: NCT03189849
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-05-10
• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in microbiota beta diversity from baseline to immediately post-camp.	Immediately post-camp
Change in the mean scores in the Youth PSC from baseline to immediately post camp.	Immediately post camp
Change in the mean scores in the WHO-5 from baseline to immediately post camp.	Immediately post camp
Change in the mean scores in the EmQue-CA from baseline to immediately post camp.	Immediately post camp
Change in microbiota alpha diversity from baseline to immediately post-camp.	Immediately post-camp
Change in the mean scores in the PSC-35 from baseline to immediately post camp.	Immediately post camp

Secondary Outcome Measures

Name	Time	Method
Change in microbiota beta diversity from baseline to month 1.	1 month post-camp
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

Trial Locations

Locations (1)

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States