NCT06574724

Brief Summary

The goal of this study is to understand how visiting green areas affects the human microbiome through microbial transfer. Additionally, the project aims to understand which environmental, health and lifestyle factors can influence these microbiome changes. Participants will visit a green area, provide microbiome samples before and after the visit, and complete questionnaires related to environmental, health, lifestyle and demographic factors.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress63%
Aug 2024Jul 2027

First Submitted

Initial submission to the registry

August 22, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

August 27, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2027

Last Updated

December 5, 2024

Status Verified

August 1, 2024

Enrollment Period

2.9 years

First QC Date

August 22, 2024

Last Update Submit

December 3, 2024

Conditions

Keywords

green areasnaturemicrobiomebiodiversitysequencing

Outcome Measures

Primary Outcomes (1)

  • Microbiome changes

    Microbiome sequencing will be performed to assess changes in microbial community composition of nasal and skin swabs, focusing on abundances and diversity of different microorganisms and their genes

    Two time points directly before and after the intervention (on 1 day)

Secondary Outcomes (2)

  • Specific microorganisms within the skin and nasal microbiomes

    Two time points directly before and after the intervention (on 1 day)

  • Associations between the human microbiome and environment

    Two time points directly before and after the intervention (on 1 day)

Other Outcomes (3)

  • Self-reported lifestyle

    One time point directly before or after the intervention (on 1 day)

  • Self-reported health

    One time point directly before or after the intervention (on 1 day)

  • Self-reported demographic information

    One time point directly before or after the intervention (on 1 day)

Study Arms (1)

Green space intervention

EXPERIMENTAL

Participants that visit a green space

Other: Visiting a green space

Interventions

Participants are asked to visit a green space for a defined time period

Green space intervention

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children (min. 4 years old) and adult participants (18+) of any gender in generally good health.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiteit Antwerpen

Antwerp, 2020, Belgium

RECRUITING

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Irina Spacova, Prof.

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR
  • Stijn Verhulst, Prof. dr.

    Universiteit Antwerpen and University Hospital Antwerp (UZA)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 22, 2024

First Posted

August 28, 2024

Study Start

August 27, 2024

Primary Completion (Estimated)

July 7, 2027

Study Completion (Estimated)

July 7, 2027

Last Updated

December 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations