Microbial ColonizationBIWENCT06353035
Biodiversity Interventions for Well-Being
A study testing Rewilding in people with Microbial Colonization and Immune System Diseases, run by Natural Resources Institute Finland at 1 site in Finland.
Trial summary
Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities, which weakens the functionality of the urban ecosystems and the well-being of citizens. This may also increase the risk of immune-mediated disorders among urban dwellers. Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Immune System Diseases, Well-Being, Psychological
- What is being tested?
- Rewilding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 30 Mar 2022to 30 Sep 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 18 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Living in a detached or terraced house in urban area
Who cannot join
- Immunosuppressive medications
- Immune deficiencies
- a disease affecting immune response (e.g., colitis ulcerosa, rheumatoid arthritis, Crohn's disease, diabetes)
- cancer diagnosis within the last year or on-going cancer treatment
- Incompetency
- Living outside city area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biodiversity Interventions for Well-being, Neighborhood Rewilding
Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities, which weakens the functionality of the urban ecosystems and the well-being of citizens. This may also increase the risk of immune-mediated disorders among urban dwellers.
In Biodiversity interventions for well-being (BIWE), microbial biodiversity interventions are performed to increase biodiversity in urban built areas. Results from the intervention trials are combined with publicly available land cover and ecological data. These are analyzed from the viewpoint of shifts in ecosystems and human well-being and immune regulation, ecological quality, and urban planning.
The investigators set up an intervention study in which urban private yards are rewilded with diverse vegetation and decaying deadwood and plant residuals. The investigators aim to evaluate the effect of rewilding, and yard management practices on commensal microbiome, cortisol levels and well-being and salivary cytokine levels, and gene pathways.
Read the detailed description
Our specific aims are:
To assess if rewilding diversifies health-associated skin microbiota and is associated with salivary cytokine levels, gene pathways, cortisol levels and commensal microbiota.
Assess whether there are patterns in the microbiome associated with the salivary cytokine levels and hair cortisol levels.
Assess whether rewilding affects health and psychological measures, such as Perceived Stress Scale (PSS), Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS), Depression Scale (DEPS) and Nature Relatedness Scale (NR6).
The investigators will recruit approximately 42 (21 study subjects per treatment) subjects living in a detached house or terraced house in urban areas and aged between 18-72.
The medical exclusion criteria include immunosuppressive medications, immune deficiencies, a disease affecting immune response (e.g., colitis ulcerosa, rheumatoid arthritis, Crohn's disease, diabetes), cancer diagnosis within the last year or on-going cancer treatment. Other exclusion criteria include incompetency and living outside city area.
- Being tested
- Rewilding
- Keywords
- Commensal microbiome, Salivary cytokines, Planetary health, Well-being
- Medical subject headings
- Communicable Diseases, Immune System Diseases, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RewildingOther
Private yards of the intervention study subjects will be modified with vegetation and deadwood.
| Study group | Role | What they receive |
|---|---|---|
| Rewilding | Experimental | Private yards of the intervention study subjects will be modified with berry bushes, fruit trees, perennial yard plants, meadow flowers, cultivation boxes, organic mulch materials, decaying deadwood, leaf compost and organic plant growing media with high microbial diversity. Receives: Other: Rewilding |
| Control | No intervention | The control group's yards will not be modified. Control group receives inorganic fertilizers, moss remover and ant control insecticide (Myrr®; active ingredient imidacloprid 0.03 % w/w). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Gammaproteobacteria
Difference on skin gammaproteobacterial diversity between rewilding and control group
Measured: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary outcomes (11)
Salivary cytokines
Interleukin-6 and -10 measured from saliva
Measured: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Difference in diversity (Alpha and beta diversity) of skin, saliva and stool microbiota
It will be analyzed if microbial communities are different between treatments
Measured: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Difference in observed species richness of skin, saliva and stool microbiota
It will be analyzed if microbial communities are different between treatments
Measured: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Difference in taxonomies of skin, saliva and stool microbiota
It will be analyzed if microbial communities are different between treatments
Measured: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Difference in microbial gene pathways of saliva and stool microbiota
Will be analyzed with shotgun sequencing if gene pathways are different between treatments
Measured: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Cortisol levels
Cortisol levels measured from hair samples
Measured: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Perceived Stress Scale
Lower score on a perceived stress scale among intervention treatment compared to control that indicates lower perceived stress levels among intervention treatment. Minimum 0, maximum 40.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Warwick-Edinburgh Mental Wellbeing Scale
Higher score on a Warwick-Edinburhg Mental Wellbeing scale among intervention treatment compared to control that indicates better mental well-being among intervention treatment. Minimum 14, maximum 70.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Depression Scale
Lower score on a Depression scale among intervention treatment compared to control that indicates lower levels of depression symptoms among intervention treatment. Minimum 0, maximum 60.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Nature Relatedness Scale
Higher score on a Nature Relatedness scale among intervention treatment compared to control that indicates stronger sense of connectedness to nature among intervention treatment. Minimum 6, maximum 30.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Metabolites in urine
Metabolites of harmful substances are measured from the urine sample.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start30 Mar 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention-control study in which intervention study subjects private yards are rewilded and control receives no treatment.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Resources Institute Finland
- Sponsor type
- Other government
- Collaborators
- Tampere University
- Responsible party
- Sponsor
- Investigators
- Aki Sinkkonen, Principal investigator, Natural Resources Institute Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353035
- Sponsor's protocol ID
- NaturalResourcesIFinland
- Other IDs
- 346136, 346138
- Acronym
- BIWE
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodiversity Interventions for Well-being, Neighborhood Rewilding
- ClinicalTrials.gov ID
- NCT06353035
- Acronym / sponsor ID
- BIWE / NaturalResourcesIFinland
- Keywords
- Commensal microbiome, Salivary cytokines, Planetary health, Well-being
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Natural Resources Institute FinlandOther government
- Collaborators
- Tampere University
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 8 Apr 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.
Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities, which weakens the functionality of the urban ecosystems and the well-being of citizens. This may also increase the risk of immune-mediated disorders among urban dwellers.
In Biodiversity interventions for well-being (BIWE), microbial biodiversity interventions are performed to increase biodiversity in urban built areas. Results from the intervention trials are combined with publicly available land cover and ecological data. These are analyzed from the viewpoint of shifts in ecosystems and human well-being and immune regulation, ecological quality, and urban planning.
The investigators set up an intervention study in which urban private yards are rewilded with diverse vegetation and decaying deadwood and plant residuals. The investigators aim to evaluate the effect of rewilding, and yard management practices on commensal microbiome, cortisol levels and well-being and salivary cytokine levels, and gene pathways.
Detailed description
Our specific aims are:
To assess if rewilding diversifies health-associated skin microbiota and is associated with salivary cytokine levels, gene pathways, cortisol levels and commensal microbiota.
Assess whether there are patterns in the microbiome associated with the salivary cytokine levels and hair cortisol levels.
Assess whether rewilding affects health and psychological measures, such as Perceived Stress Scale (PSS), Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS), Depression Scale (DEPS) and Nature Relatedness Scale (NR6).
The investigators will recruit approximately 42 (21 study subjects per treatment) subjects living in a detached house or terraced house in urban areas and aged between 18-72.
The medical exclusion criteria include immunosuppressive medications, immune deficiencies, a disease affecting immune response (e.g., colitis ulcerosa, rheumatoid arthritis, Crohn's disease, diabetes), cancer diagnosis within the last year or on-going cancer treatment. Other exclusion criteria include incompetency and living outside city area.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention-control study in which intervention study subjects private yards are rewilded and control receives no treatment.
| Arm | Type | Receives |
|---|---|---|
| Rewilding | Experimental | Other: RewildingPrivate yards of the intervention study subjects will be modified with berry bushes, fruit trees, perennial yard plants, meadow flowers, cultivation boxes, organic mulch materials, decaying deadwood, leaf compost and organic plant growing media with high microbial diversity. |
| Control | No intervention | –The control group's yards will not be modified. Control group receives inorganic fertilizers, moss remover and ant control insecticide (Myrr®; active ingredient imidacloprid 0.03 % w/w). |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Living in a detached or terraced house in urban area
Key exclusion criteria (6 listed)
- Immunosuppressive medications
- Immune deficiencies
- a disease affecting immune response (e.g., colitis ulcerosa, rheumatoid arthritis, Crohn's disease, diabetes)
- cancer diagnosis within the last year or on-going cancer treatment
- Incompetency
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 |
|---|---|---|
| RewildingPrivate yards of the intervention study subjects will be modified with vegetation and deadwood. | Other | Rewilding |
Primary outcome
Skin Gammaproteobacteria
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Difference on skin gammaproteobacterial diversity between rewilding and control group
11 secondary outcomes
Salivary cytokines
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Difference in diversity (Alpha and beta diversity) of skin, saliva and stool microbiota
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Difference in observed species richness of skin, saliva and stool microbiota
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Difference in taxonomies of skin, saliva and stool microbiota
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Difference in microbial gene pathways of saliva and stool microbiota
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Cortisol levels
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Perceived Stress Scale
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Warwick-Edinburgh Mental Wellbeing Scale
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Depression Scale
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Nature Relatedness Scale
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Metabolites in urine
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
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 8 Apr 2024.
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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. This study is not recruiting at the moment.
Aki Sinkkonen principal investigator
Natural Resources Institute Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rewilding in people with Microbial Colonization and Immune System Diseases, run by Natural Resources Institute Finland at 1 site in Finland.
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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 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 Finland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Gammaproteobacteria (time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year). 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 8 Apr 2024.