Atopic DisordersImmunoG1NCT03997175
Effect of Modified Playground Environment on Health, Particularly Immune System
A study testing Biodiversity powder in people with Atopic Disorders and Immune System Diseases, run by University of Helsinki at 1 site in Finland.
Trial summary
Children were exposed to biodiverse material or non-diverse material in sand pits. The two arms were compared. Immune response and bacterial markers were followed. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Disorders, Immune System Diseases
- What is being tested?
- Biodiversity powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteFinland
- Study dates
- 15 Apr 2018to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy
- born in Finland
- spends daily (5 d a week) several hours in one of the daycares in which the trial was performed
Who cannot join
- medication affecting immune system function
- medication affecting microbiota
- cancer
- immune deficiency
- living on a farm
- not born in Finland
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ImmunoGarden - Effect of Modified Playground Environment on Health, Particularly Immune System
Children were exposed to biodiverse material or non-diverse material in sand pits. The two arms were compared. Immune response and bacterial markers were followed.
Read the detailed description
Children of age 3-5 were randomly divided into two groups (arms). One received guidance and biodiverse material for 20 minutes each day for two weeks. The other received the a similar material and guidance but the microbial community in the material was poor in diversity. Bacterial community changes and immune system markers were analyzed and compared between the two arms. Potential changes in Interleukin 10 was the primary outcome.
- Conditions
- Atopic Disorders, Immune System Diseases
- Being tested
- Biodiversity powder, Placebo
- Keywords
- biodiversity intervention, sand box, guidance
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodiversity powderOther
Also called Biodiversity sand, Biodiversity intervention
Biodiversity sand contained biodiversity powder that contains a highly diverse and rich microbial community but no known pathogens.
PlaceboOther
Also called Placebo sand
Sand that looks like intervention sand but does not have high biodiversity
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The children were in daily contact with biodiversity sand 5 days a week for two weeks. Receives: Other: Biodiversity powder |
| Placebo | Placebo comparator | Children were in contact with normal but colored sand that looked as it were the biodiversity sand. All the other details were as above. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interleukin 10 level in blood
The difference between day 0 and a follow up day in intervention
Measured: two weeks
Secondary outcomes (5)
changes in microbiota
all potential changes in bacterial profile are measured on skin and stool samples
Measured: two weeks
changes in interleukin 17 levels
all measured changes in interleukin 17 levels
Measured: two weeks
changes in tgf-beta levels
change in tgf-beta levels
Measured: two weeks
ratio il-10 / il-17
potential changes in the ratio of these two citokines
Measured: two weeks
long-term changes in microbiota
potential changes that last for four weeks
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start15 Apr 2018
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One arm received biodiversity sand and the other arm normal sand.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Principal investigator, Aki Sinkkonen, University of Helsinki
- Investigators
- Aki Sinkkonen, ph d, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997175
- Sponsor's protocol ID
- HelsinkiUIG1
- Acronym
- ImmunoG1
- Status last verified
- Jun 2019
- First submitted
- 23 Jun 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The local ethical committee and the law in Finland retricts the sharing of information that could lead to distinguishing a study participant. Microbial information is considered to faciliation the identification of study participants. Microbial information will be partly shared to public databases (sequences).
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImmunoGarden - Effect of Modified Playground Environment on Health, Particularly Immune System
- ClinicalTrials.gov ID
- NCT03997175
- Acronym / sponsor ID
- ImmunoG1 / HelsinkiUIG1
- Conditions
- Atopic Disorders, Immune System Diseases
- Keywords
- biodiversity intervention, sand box, guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children were exposed to biodiverse material or non-diverse material in sand pits. The two arms were compared. Immune response and bacterial markers were followed.
Detailed description
Children of age 3-5 were randomly divided into two groups (arms). One received guidance and biodiverse material for 20 minutes each day for two weeks. The other received the a similar material and guidance but the microbial community in the material was poor in diversity. Bacterial community changes and immune system markers were analyzed and compared between the two arms. Potential changes in Interleukin 10 was the primary outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- One arm received biodiversity sand and the other arm normal sand.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Biodiversity powderThe children were in daily contact with biodiversity sand 5 days a week for two weeks. |
| Placebo | Placebo comparator | Other: PlaceboChildren were in contact with normal but colored sand that looked as it were the biodiversity sand. All the other details were as above. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- healthy
- born in Finland
- spends daily (5 d a week) several hours in one of the daycares in which the trial was performed
Key exclusion criteria (6 listed)
- medication affecting immune system function
- medication affecting microbiota
- cancer
- immune deficiency
- living on a farm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biodiversity powderAlso: Biodiversity sand, Biodiversity interventionBiodiversity sand contained biodiversity powder that contains a highly diverse and rich microbial community but no known pathogens. | Other | Intervention |
| PlaceboAlso: Placebo sandSand that looks like intervention sand but does not have high biodiversity | Other | Placebo |
Primary outcome
Change in Interleukin 10 level in blood
Time frame: two weeks
The difference between day 0 and a follow up day in intervention
5 secondary outcomes
changes in microbiota
Time frame: two weeks
changes in interleukin 17 levels
Time frame: two weeks
changes in tgf-beta levels
Time frame: two weeks
ratio il-10 / il-17
Time frame: two weeks
long-term changes in microbiota
Time frame: four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: Undecided. The local ethical committee and the law in Finland retricts the sharing of information that could lead to distinguishing a study participant. Microbial information is considered to faciliation the identification of study participants. Microbial information will be partly shared to public databases (sequences).
Related trials for Atopic Disorders
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aki Sinkkonen, ph d principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodiversity powder in people with Atopic Disorders and Immune System Diseases, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Interleukin 10 level in blood (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.