AtopyPREVALLNCT03872219
Biodiversity Intervention and Atopic Sensitization
A study testing Nature-based materials in people with Atopy and Allergy, run by University of Helsinki.
Trial summary
Children will receive biodiversity intervention or placebo. The proof of concept trial is double blind. Intervention will start at the age of 2 months and last 10 months. Children will be randomized to arms. IgE sensitization is the primary outcome. Read more about this study
- Who is it for?
- Ages Up to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Atopy, Allergy, Allergic Rhinitis
- What is being tested?
- Nature-based materials
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2019to 31 Dec 2025
- 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 Up to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- both parents have atopy
- newborn
Who cannot join
- severe disease, particularly immune system deficiency or down syndrome or cancer
- medication affecting immune system
- birth before week 35 in pregnancy
- being a twin
- only one of the parents have atopy
- none of the parents have atopy
Show all 9Show fewer
- children have passed the age of two months
- immune system disorder such as rheumatoid disease, colitis ulcerosa, Crohn disease, diabetes or genetic risk to type 1 diabetes
- no participation in national vaccination programme
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Plant and Soil-based Material on the Incidence of Atopic Sensitization
Children will receive biodiversity intervention or placebo. The proof of concept trial is double blind. Intervention will start at the age of 2 months and last 10 months. Children will be randomized to arms. IgE sensitization is the primary outcome.
Read the detailed description
Newborns will start to be exposed to biodiversity intervention or placebo at the age of two months. The proof of concept trial will be double blind. Intervention will start at the age of 2 months and it will end when children become 12 months old. Children will be randomized to the two arms. IgE sensitization is the primary outcome at the age of two and three years.
- Conditions
- Atopy, Allergy, Allergic Rhinitis, Allergic Sensitisation
- Being tested
- Nature-based materials
- Keywords
- biodiversity intervention, IgE, atopy
- Medical subject headings
- Hypersensitivity, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature-based materialsCombination product
In the intervention arm, theycontain inactive and slowly-growing environmental bacteria and other microbiota. In the placebo arm, they do not contain the microbiota.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The children will receive and they are exposed daily to harmless materials that look and feel like the biodiversity intervention materials. Receives: Combination Product: Nature-based materials |
| intervention arm | Experimental | The children will receive and they are exposed daily to materials of high microbiological biodiversity. Receives: Combination Product: Nature-based materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgE sensitization
IgE sentitization is expected to be lower in the intervention arm than in the placebo arm.
Measured: 2-3 years
Secondary outcomes (1)
Allergic symptoms
All possible allergic symptomes, including atopy, will be estimated
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start25 Mar 2019 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtopyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two arms, the intervention arm and the placebo arm. Children are randomized into the arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri), Business Finland (National Innovation Agency)
- Responsible party
- Principal investigator, Aki Sinkkonen, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872219
- Sponsor's protocol ID
- HelsinkiUAdele2poc
- Acronym
- PREVALL
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share it according to Finnish legislation and ethical committee permission. The permission restrict sharing tightly.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Plant and Soil-based Material on the Incidence of Atopic Sensitization
- ClinicalTrials.gov ID
- NCT03872219
- Acronym / sponsor ID
- PREVALL / HelsinkiUAdele2poc
- Conditions
- Atopy, Allergy, Allergic Rhinitis, Allergic Sensitisation
- Keywords
- biodiversity intervention, IgE, atopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Tampere University, Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri), Business Finland (National Innovation Agency)
- Study start
- 25 Mar 2019 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Mar 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 will receive biodiversity intervention or placebo. The proof of concept trial is double blind. Intervention will start at the age of 2 months and last 10 months. Children will be randomized to arms. IgE sensitization is the primary outcome.
Detailed description
Newborns will start to be exposed to biodiversity intervention or placebo at the age of two months. The proof of concept trial will be double blind. Intervention will start at the age of 2 months and it will end when children become 12 months old. Children will be randomized to the two arms. IgE sensitization is the primary outcome at the age of two and three years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study consists of two arms, the intervention arm and the placebo arm. Children are randomized into the arms.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Combination Product: Nature-based materialsThe children will receive and they are exposed daily to harmless materials that look and feel like the biodiversity intervention materials. |
| intervention arm | Experimental | Combination Product: Nature-based materialsThe children will receive and they are exposed daily to materials of high microbiological biodiversity. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- both parents have atopy
- newborn
Key exclusion criteria (9 listed)
- severe disease, particularly immune system deficiency or down syndrome or cancer
- medication affecting immune system
- birth before week 35 in pregnancy
- being a twin
- only one of the parents have atopy
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 |
|---|---|---|
| Nature-based materialsIn the intervention arm, theycontain inactive and slowly-growing environmental bacteria and other microbiota. In the placebo arm, they do not contain the microbiota. | Combination product | Placebo, intervention arm |
Primary outcome
IgE sensitization
Time frame: 2-3 years
IgE sentitization is expected to be lower in the intervention arm than in the placebo arm.
1 secondary outcome
Allergic symptoms
Time frame: 2-3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No. We will share it according to Finnish legislation and ethical committee permission. The permission restrict sharing tightly.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Nature-based materials in people with Atopy and Allergy, run by University of Helsinki.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aki Sinkkonen (358 2941 20315, aki.sinkkonen@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgE sensitization (time frame: 2-3 years). 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 13 Mar 2019.