NCT06353035

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 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
17mo left

Started Mar 2022

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 Progress75%
Mar 2022Sep 2027

Study Start

First participant enrolled

March 30, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 8, 2024

Status Verified

March 1, 2024

Enrollment Period

5.3 years

First QC Date

March 27, 2024

Last Update Submit

April 3, 2024

Conditions

Keywords

Commensal microbiomeSalivary cytokinesPlanetary healthWell-being

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Salivary cytokines

    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

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

  • Difference in observed species richness of skin, saliva and stool microbiota

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

  • Difference in taxonomies of skin, saliva and stool microbiota

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

  • Difference in microbial gene pathways of saliva and stool microbiota

    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 microbial measurements, salivary cytokine levels, hair cortisol levels, perceived well-being

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

Study Arms (2)

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.

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).

Interventions

Private yards of the intervention study subjects will be modified with vegetation and deadwood.

Rewilding

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living in a detached or terraced house in urban area

You may not qualify if:

  • 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.

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 DiseasesImmune System DiseasesPsychological Well-Being

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Study Officials

  • Aki Sinkkonen

    Natural Resources Institute Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
The research subjects were not randomized or masked to the intervention and control group, because the control group needs volunteers who have no intention of following the yard management instructions advised to the intervention group.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Intervention-control study in which intervention study subjects private yards are rewilded and control receives no treatment.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 8, 2024

Study Start

March 30, 2022

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

April 8, 2024

Record last verified: 2024-03

Locations