Microbial ColonizationNCT06574724
Transfer of Microorganisms Between Green Areas and Humans
A study testing Visiting a green space in people with Microbial Colonization, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Visiting a green space
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Aug 2024to 7 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universiteit Antwerpen
Antwerp, 2020
Irina Spacova, Prof., +32 3 265 32 89, irina.spacova@uantwerpen.be
About this study
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.
Read the 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.
- Conditions
- Microbial Colonization
- Being tested
- Visiting a green space
- Keywords
- green areas, nature, microbiome, biodiversity, sequencing
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visiting a green spaceOther
Participants are asked to visit a green space for a defined time period
| Study group | Role | What they receive |
|---|---|---|
| Green space intervention | Experimental | Participants that visit a green space Receives: Other: Visiting a green space |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome changes
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
Measured: Two time points directly before and after the intervention (on 1 day)
Secondary outcomes (2)
Specific microorganisms within the skin and nasal microbiomes
Specific microorganisms within the participants' microbiomes will be assessed through culturing of swabs and/or quantification via qPCR
Measured: Two time points directly before and after the intervention (on 1 day)
Associations between the human microbiome and environment
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
Measured: Two time points directly before and after the intervention (on 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start27 Aug 2024
- Primary completion7 Jul 2027 (estimated)
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irina Spacova, Universiteit Antwerpen
- Investigators
- Irina Spacova, Prof., Principal investigator, Universiteit AntwerpenStijn Verhulst, Prof. dr., Principal investigator, Universiteit Antwerpen and University Hospital Antwerp (UZA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574724
- Sponsor's protocol ID
- B3002024000110
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer of Microorganisms Between Green Areas and Humans
- ClinicalTrials.gov ID
- NCT06574724
- Acronym / sponsor ID
- B3002024000110
- Conditions
- Microbial Colonization
- Keywords
- green areas, nature, microbiome, biodiversity, sequencing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 7 Jul 2027 (estimated)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Green space intervention | Experimental | Other: Visiting a green spaceParticipants that visit a green space |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visiting a green spaceParticipants are asked to visit a green space for a defined time period | Other | Green space intervention |
Primary outcome
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
2 secondary outcomes
Specific microorganisms within the skin and nasal microbiomes
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irina Spacova, Prof. principal investigator
Universiteit Antwerpen
Stijn Verhulst, Prof. dr. principal investigator
Universiteit Antwerpen and University Hospital Antwerp (UZA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visiting a green space in people with Microbial Colonization, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irina Spacova, Prof. (+32 3 265 32 89, irina.spacova@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome changes (time frame: Two time points directly before and after the intervention (on 1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.