- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06353035
Biodiversity Interventions for Well-Being (BIWE)
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Uusimaa
-
Helsinki, Uusimaa, Finland, 00970
- Natural Resources Institute Finland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Living in a detached or terraced house in urban area
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rewilding
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.
|
Private yards of the intervention study subjects will be modified with vegetation and deadwood.
|
No Intervention: Control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary cytokines
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
|
Interleukin-6 and -10 measured from saliva
|
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
|
It will be analyzed if microbial communities are different between treatments
|
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
|
It will be analyzed if microbial communities are different between treatments
|
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
|
It will be analyzed if microbial communities are different between treatments
|
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
|
Will be analyzed with shotgun sequencing if gene pathways are different between treatments
|
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
|
Cortisol levels measured from hair samples
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
Metabolites of harmful substances are measured from the urine sample.
|
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Associations between environmental factors and microbial measurements, salivary cytokine levels, hair cortisol levels, perceived well-being
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
|
associations between environmental factors (vegetation, deadwood, and polypore richness, land cover categories and other yard characteristics), yard management practices, activities at the yard, salivary cytokine levels and bacterial measurements (diversity, and taxonomic and functional features).
|
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Aki Sinkkonen, Natural Resources Institute Finland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NaturalResourcesIFinland
- 346136 (Other Grant/Funding Number: Strategic Research Council Finland)
- 346138 (Other Grant/Funding Number: Strategic Research Council Finland)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Immune System Diseases
-
University of HelsinkiTampere UniversityCompletedImmune System DisordersFinland
-
Kadmon, a Sanofi CompanyCompletedImmune System Disorder (Healthy Volunteers)United States
-
Kadmon, a Sanofi CompanyCompletedImmune System Disorder (Healthy Volunteer)United States
-
Kadmon, a Sanofi CompanyCompletedImmune System Disorder (Healthy Volunteer)United States
-
Kadmon, a Sanofi CompanyCompletedImmune System Disorder (Healthy Volunteer)United States
-
SanofiTerminatedImmune System DisorderUnited States, Spain
-
National Heart, Lung, and Blood Institute (NHLBI)National Cancer Institute (NCI); Blood and Marrow Transplant Clinical Trials...CompletedGraft vs Host Disease | Immune System DisordersUnited States
-
Shanghai Henlius BiotechCompleted
-
University Hospital, LimogesCompleted
-
University Hospital, LilleLaboratoire français de Fractionnement et de BiotechnologiesCompleted
Clinical Trials on Rewilding
-
Natural Resources Institute FinlandTampere UniversityActive, not recruitingAutism Spectrum Disorder | Microbial Colonization | Visual Impairment | Immune System and Related Disorders | Nature, Human | Well-Being, PsychologicalFinland