Biodiversity Interventions for Well-Being

Microbial Colonization Clinical Trial

— BIWE  

Official title:

Biodiversity Interventions for Well-being, Neighborhood Rewilding

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06353035
• Other study ID #: NaturalResourcesIFinland
• Secondary ID: 346136346138
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: September 30, 2027

Study information

• Verified date: March 2024
• Source: Natural Resources Institute Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Immune System Diseases
• Infections
• Microbial Colonization

Intervention

Other:
• Rewilding
Private yards of the intervention study subjects will be modified with vegetation and deadwood.

Locations

Country	Name	City	State
Finland	Natural Resources Institute Finland	Helsinki	Uusimaa

Sponsors (2)

Lead Sponsor	Collaborator
Natural Resources Institute Finland	Tampere University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Associations between environmental factors and microbial measurements, salivary cytokine levels, hair cortisol levels, perceived well-being	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
Primary	Skin Gammaproteobacteria	Difference on skin gammaproteobacterial diversity between rewilding and control group	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	Salivary cytokines	Interleukin-6 and -10 measured from saliva	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	Difference in diversity (Alpha and beta diversity) of skin, saliva and stool microbiota	It will be analyzed if microbial communities are different between treatments	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	Difference in observed species richness of skin, saliva and stool microbiota	It will be analyzed if microbial communities are different between treatments	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	Difference in taxonomies of skin, saliva and stool microbiota	It will be analyzed if microbial communities are different between treatments	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	Difference in microbial gene pathways of saliva and stool microbiota	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
Secondary	Cortisol levels	Cortisol levels measured from hair samples	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	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.	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	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.	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	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.	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	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.	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	Metabolites in urine	Metabolites of harmful substances are measured from the urine sample.	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year