NCT06390683

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Feb 2023Sep 2027

Study Start

First participant enrolled

February 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

4.7 years

First QC Date

April 25, 2024

Last Update Submit

April 25, 2024

Conditions

Nature, HumanMicrobial ColonizationWell-Being, PsychologicalImmune System and Related DisordersAutism Spectrum DisorderVisual Impairment

Keywords

BiodiversityWell-beingPlanetary healthCommensal microbiomeImmune system

Outcome Measures

Primary Outcomes (1)

  • Skin Gammaproteobacteria

    Change in skin gammaproteobacterial diversity

    Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

Secondary Outcomes (11)

  • Salivary cytokines

    Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

  • Skin bacteria

    Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

  • Saliva microbiota

    Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

  • Saliva gene pathways

    Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

  • Cortisol levels

    Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

  • +6 more secondary outcomes

Other Outcomes (1)

  • Associations between environmental factors and primary and secondary outcomes

    Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

Study Arms (1)

Rewilding

EXPERIMENTAL

Yards of the housing units are rewilded with vegetation, deadwood and plant residuals.

Other: Rewilding

Interventions

RewildingOTHER

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.

Rewilding

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Person lives in assisted living center

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Natural Resources Institute Finland

Helsinki, Uusimaa, 00970, Finland

Location

MeSH Terms

Conditions

Communicable DiseasesPsychological Well-BeingAutism Spectrum DisorderVision Disorders

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPersonal SatisfactionBehaviorChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and Symptoms

Study Officials

  • Aki Sinkkonen

    Natural Resources Institute Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2024

First Posted

April 30, 2024

Study Start

February 1, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations

FI(1)