Farms, Animals and Adolescents: Reinforcing the Microbiome



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:7 - 13
Updated:10/28/2017
Start Date:May 10, 2017
End Date:September 30, 2017

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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.

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.

Inclusion Criteria for Children:

- Males and females ages 7-13 years

- Able to attend camp at Heartland Farm Sanctuary for either 1, 2, or 3 consecutive
weeks (if not consecutive, but within a 4-week period, this is allowable)

- In generally good health

- Have not taken antibiotics in the four weeks prior to when their first baseline set of
samples will be collected

- Have not attended camp at HFS or regular volunteer activities at HFS in the past year
(participation in previous summer HFS camp is permissible)

- Able to understand the nature of the study and able to provide assent

- Able to communicate in English with study personnel.

- Willing to commit to participating in the study and doing the home collection of
samples.

Exclusion Criteria for Children:

- Individuals who will not be able to collect the samples for any reason, including
planned vacations, unwillingness, or inability. (Note - children who are attending
either 2 or 3 weeks of camp and who take a break in between weeks of camp will be
allowed to participate if their full two or three-week camp exposure occurs within a
4-week period).

- Plan to attend camp during the fall (i.e. during their month 1 month follow-up)

- Children living in farming environments prior to camp participation

- Children with more than an average of one exposure per week to farm animals,
livestock, horses

- Individuals currently on any antibiotic therapy or who will require chronic and/or
periodic antibiotic treatment during the study period.

- Subject has a medical condition or disorder that

- Is unstable, or:

- Could interfere with the accurate assessment of safety or efficacy of the
clinical assessments, including individuals with any:

- Current participation in any clinical trial that might impact results of this
one, which includes participation in another clinical trial where any
experimental drugs are being taken as well as studies / drug trials with agents
that might affect mood and or the gastrointestinal tract.

- Reasonable likelihood for non-compliance with the protocol for any other reason, in
the opinion of the Investigator, prohibits enrollment of subject into the study.

Inclusion Criteria for Parents/Guardians:

- Parent or legal guardian of a child attending HFS summer camp and participating in
this study

- Willing to assist the child in the collection of samples as necessary

- Willing to answer questionnaire about their child's participation in the study

- Able to communicate in English with study personnel

Exclusion Criteria for Parents/Guardians:

- Unwilling to assist their child in collection of the samples for this study

- Unwilling to answer questionnaire about their child's participation in the study

- Unable to communicate in English with study personnel
We found this trial at
1
site
Madison, Wisconsin 53706
(608) 263-2400
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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from
Madison, WI
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