Biodiversity Interventions for Assisted Living Centers

Autism Spectrum Disorder Clinical Trial

— BIWE  

Official title:

Biodiversity Interventions for Well-Being - Research in Assisted Living Centers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06390683
• Other study ID #: HUS/11940/2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: April 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 assisted living centers (BIWE 2), microbial biodiversity interventions are performed to increase biodiversity in urban housing units for people with autism spectrum disorder, disabled people and elderly. 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 yards of the housing units 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. The investigators will recruit approximately 36 study subjects living in assisted housing units in urban areas and aged between 18-82.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 82 Years

Eligibility

Inclusion Criteria:

• Person lives in assisted living center

Exclusion Criteria:

• Immunosuppressive medications

• Immune deficiencies

• a disease affecting immune response (colitis ulcerosa, rheumatoid arthritis, Crohn's disease, diabetes)

• cancer diagnosis within the last year or on-going cancer treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Communicable Diseases
• Immune System and Related Disorders
• Infections
• Microbial Colonization
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Other:
• Rewilding
Yards of the assisted living centers 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.

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 primary and secondary outcomes	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 and hair cortisol levels, prevalence of infectious diseases, psychological parameters, and microbial measurements (diversity, and taxonomic and functional features).	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Primary	Skin Gammaproteobacteria	Change in skin gammaproteobacterial diversity	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	Skin bacteria	Changes in skin bacteria are analyzed with Illumina 16s rRNA sequencing.	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	Saliva microbiota	Changes in saliva microbiota are analyzed with shotgun sequencing.	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	Saliva gene pathways	Changes in salivary gene pathways are analyzed with shotgun sequencing.	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	Decrease in perceived stress scale score during the study period that indicates lower perceived stress levels. Minimum 0, maximum 40.	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	Warwick-Edinburgh Mental Wellbeing Scale	Increase in Warwick-Edinburhg Mental Wellbeing scale score during the study period that indicates better mental well-being. Minimum 14, maximum 70.	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	Depression Scale	Decrease in depression scale score during the study period that indicates lower levels of depression symptoms. Minimum 0, maximum 70.	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	Nature Relatedness Scale	Increase in Nature Relatedness scale during the study period that indicates stronger sense of connectedness to nature. Minimum 6, maximum 30.	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	Changes in nature contacts	Increase in time that study subjects are in contact with nature during the study period.	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	Infectious diseases	Infectious diseases are recorded with questionnaires.	Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year