search
Back to results

Biodiversity Intervention and Atopic Sensitization (PREVALL)

Primary Purpose

Atopy, Allergy, Allergic Rhinitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nature-based materials
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atopy focused on measuring biodiversity intervention, IgE, atopy

Eligibility Criteria

undefined - 1 Month (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • both parents have atopy
  • newborn

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    intervention arm

    Arm Description

    The children will receive and they are exposed daily to harmless materials that look and feel like the biodiversity intervention materials.

    The children will receive and they are exposed daily to materials of high microbiological biodiversity.

    Outcomes

    Primary Outcome Measures

    IgE sensitization
    IgE sentitization is expected to be lower in the intervention arm than in the placebo arm.

    Secondary Outcome Measures

    Allergic symptoms
    All possible allergic symptomes, including atopy, will be estimated

    Full Information

    First Posted
    March 11, 2019
    Last Updated
    March 11, 2019
    Sponsor
    University of Helsinki
    Collaborators
    Tampere University, Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri), Business Finland (National Innovation Agency)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03872219
    Brief Title
    Biodiversity Intervention and Atopic Sensitization
    Acronym
    PREVALL
    Official Title
    The Effect of Plant and Soil-based Material on the Incidence of Atopic Sensitization
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 25, 2019 (Anticipated)
    Primary Completion Date
    August 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Helsinki
    Collaborators
    Tampere University, Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri), Business Finland (National Innovation Agency)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopy, Allergy, Allergic Rhinitis, Allergic Sensitisation
    Keywords
    biodiversity intervention, IgE, atopy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study consists of two arms, the intervention arm and the placebo arm. Children are randomized into the arms.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Double-blind randomized trial
    Allocation
    Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    The children will receive and they are exposed daily to harmless materials that look and feel like the biodiversity intervention materials.
    Arm Title
    intervention arm
    Arm Type
    Experimental
    Arm Description
    The children will receive and they are exposed daily to materials of high microbiological biodiversity.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Nature-based materials
    Intervention Description
    In the intervention arm, theycontain inactive and slowly-growing environmental bacteria and other microbiota. In the placebo arm, they do not contain the microbiota.
    Primary Outcome Measure Information:
    Title
    IgE sensitization
    Description
    IgE sentitization is expected to be lower in the intervention arm than in the placebo arm.
    Time Frame
    2-3 years
    Secondary Outcome Measure Information:
    Title
    Allergic symptoms
    Description
    All possible allergic symptomes, including atopy, will be estimated
    Time Frame
    2-3 years
    Other Pre-specified Outcome Measures:
    Title
    IL-10: IL-17 ratio
    Time Frame
    2-3 years
    Title
    TGF-beta level
    Time Frame
    2-3 years
    Title
    IL-10 levels
    Time Frame
    2-3 years

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    1 Month
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: both parents have atopy newborn Exclusion Criteria: 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aki Sinkkonen
    Phone
    358 2941 20315
    Email
    aki.sinkkonen@helsinki.fi
    First Name & Middle Initial & Last Name or Official Title & Degree
    Riikka Puhakka
    Phone
    358 50 3199363
    Email
    riikka.puhakka@helsinki.fi

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We will share it according to Finnish legislation and ethical committee permission. The permission restrict sharing tightly.

    Learn more about this trial

    Biodiversity Intervention and Atopic Sensitization

    We'll reach out to this number within 24 hrs