- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06574724
Transfer of Microorganisms Between Green Areas and Humans
December 3, 2024 updated by: Irina Spacova, Universiteit Antwerpen
The goal of this study is to understand how visiting green areas affects the human microbiome through microbial transfer.
Additionally, the project aims to understand which environmental, health and lifestyle factors can influence these microbiome changes.
Participants will visit a green area, provide microbiome samples before and after the visit, and complete questionnaires related to environmental, health, lifestyle and demographic factors.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Several hypotheses propose that the modern surge in immune disorders is related to diminished contact with nature.
Specifically, the Biodiversity hypothesis emphasizes that contact with natural environments enriches the human microbiome and is necessary for promoting immune balance.
This project aims to investigate whether visiting green areas can contribute to changes in human microbiome composition.
Additionally, the investigators aim to explore the environmental, health and lifestyle factors that can influence these microbiome changes.
Adults and/or children will be asked to visit a green space (such as an urban park) and perform specific activities (such as walking or pushing a stroller) for a defined time period.
Before and after this visit, swabs of their skin and nose will be collected to analyze microbiome changes.
In addition, questionnaires will be administered to the participants, with the goal to align microbiome changes with environmental, health, lifestyle and demographic factors.
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Irina Spacova, Prof.
- Phone Number: +32 3 265 32 89
- Email: irina.spacova@uantwerpen.be
Study Locations
-
-
-
Antwerp, Belgium, 2020
- Recruiting
- Universiteit Antwerpen
-
Contact:
- Irina Spacova, Prof.
- Phone Number: +32 3 265 32 89
- Email: irina.spacova@uantwerpen.be
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion criteria:
Children (min. 4 years old) and adult participants (18+) of any gender in generally good health.
No strict exclusion criteria will be set in advance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Green space intervention
Participants that visit a green space
|
Participants are asked to visit a green space for a defined time period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microbiome changes
Time Frame: Two time points directly before and after the intervention (on 1 day)
|
Microbiome sequencing will be performed to assess changes in microbial community composition of nasal and skin swabs, focusing on abundances and diversity of different microorganisms and their genes
|
Two time points directly before and after the intervention (on 1 day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Specific microorganisms within the skin and nasal microbiomes
Time Frame: Two time points directly before and after the intervention (on 1 day)
|
Specific microorganisms within the participants' microbiomes will be assessed through culturing of swabs and/or quantification via qPCR
|
Two time points directly before and after the intervention (on 1 day)
|
|
Associations between the human microbiome and environment
Time Frame: Two time points directly before and after the intervention (on 1 day)
|
Human microbiome composition and diversity (as assessed in outcome "Microbiome changes") will be correlated with the green space environment characteristics, such as the environmental (microbiome) biodiversity
|
Two time points directly before and after the intervention (on 1 day)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported lifestyle
Time Frame: One time point directly before or after the intervention (on 1 day)
|
Lifestyle will be assessed using a short questionnaire to understand how it might impact the microbiome (as assessed in outcome "Microbiome changes"), reflecting lifestyle-related parameters such as weekly time spent outdoors (in hours) and frequency of exposure to green environments (e.g., once a year)
|
One time point directly before or after the intervention (on 1 day)
|
|
Self-reported health
Time Frame: One time point directly before or after the intervention (on 1 day)
|
Self-reported general health will be assessed using a short questionnaire to understand how it might impact the microbiome (as assessed in outcome "Microbiome changes"), reflecting health-related parameters such as a health rating (from very poor to very good)
|
One time point directly before or after the intervention (on 1 day)
|
|
Self-reported demographic information
Time Frame: One time point directly before or after the intervention (on 1 day)
|
Demographic information will be assessed using a short questionnaire to understand how it might impact the microbiome (as assessed in outcome "Microbiome changes"), reflecting demographic parameters such as age (in years), gender, and parent-child relationship (having one or more children)
|
One time point directly before or after the intervention (on 1 day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Irina Spacova, Prof., Universiteit Antwerpen
- Principal Investigator: Stijn Verhulst, Prof. dr., Universiteit Antwerpen and University Hospital Antwerp (UZA)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 27, 2024
Primary Completion (Estimated)
July 7, 2027
Study Completion (Estimated)
July 7, 2027
Study Registration Dates
First Submitted
August 22, 2024
First Submitted That Met QC Criteria
August 24, 2024
First Posted (Actual)
August 28, 2024
Study Record Updates
Last Update Posted (Estimated)
December 5, 2024
Last Update Submitted That Met QC Criteria
December 3, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B3002024000110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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