Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03189849
Other study ID # 2017-0154
Secondary ID
Status Completed
Phase N/A
First received June 1, 2017
Last updated October 24, 2017
Start date May 10, 2017
Est. completion date September 30, 2017

Study information

Verified date October 2017
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date September 30, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 13 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Wisconsin-Madison Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in microbiota alpha diversity from baseline to immediately post-camp. Immediately post-camp
Primary Change in microbiota beta diversity from baseline to immediately post-camp. Immediately post-camp
Primary Change in the mean scores in the WHO-5 from baseline to immediately post camp. Immediately post camp
Primary Change in the mean scores in the EmQue-CA from baseline to immediately post camp. Immediately post camp
Primary Change in the mean scores in the PSC-35 from baseline to immediately post camp. Immediately post camp
Primary Change in the mean scores in the Youth PSC from baseline to immediately post camp. Immediately post camp
Secondary Change in microbiota alpha diversity from baseline to month 1. 1 month post-camp
Secondary Change in microbiota beta diversity from baseline to month 1. 1 month post-camp
Secondary Change in the mean scores in the WHO-5 from baseline to month 1. 1 month post-camp
Secondary Change in the mean scores in the EmQue-CA from baseline to month 1. 1 month post-camp
Secondary Change in the mean scores in the PSC-35 from baseline to month 1. 1 month post-camp
Secondary Change in the mean scores in the Youth PSC from baseline to month 1. 1 month post-camp
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1