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Biodiversity Intervention and Atopic Sensitization (PREVALL)

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ClinicalTrials.gov Identifier: NCT03872219
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Tampere University
Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri)
Business Finland (National Innovation Agency)
Information provided by (Responsible Party):
Aki Sinkkonen, Helsinki University

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.

Condition or disease Intervention/treatment Phase
Atopy Allergy Allergic Rhinitis Allergic Sensitisation Combination Product: Nature-based materials Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study consists of two arms, the intervention arm and the placebo arm. Children are randomized into the arms.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind randomized trial
Primary Purpose: Prevention
Official Title: The Effect of Plant and Soil-based Material on the Incidence of Atopic Sensitization
Estimated Study Start Date : March 25, 2019
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : December 31, 2025

Arm Intervention/treatment
Placebo Comparator: Placebo
The children will receive and they are exposed daily to harmless materials that look and feel like the biodiversity intervention materials.
Combination Product: Nature-based materials
In the intervention arm, theycontain inactive and slowly-growing environmental bacteria and other microbiota. In the placebo arm, they do not contain the microbiota.

Experimental: intervention arm
The children will receive and they are exposed daily to materials of high microbiological biodiversity.
Combination Product: Nature-based materials
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 Measures :
  1. IgE sensitization [ Time Frame: 2-3 years ]
    IgE sentitization is expected to be lower in the intervention arm than in the placebo arm.


Secondary Outcome Measures :
  1. Allergic symptoms [ Time Frame: 2-3 years ]
    All possible allergic symptomes, including atopy, will be estimated


Other Outcome Measures:
  1. IL-10: IL-17 ratio [ Time Frame: 2-3 years ]
  2. TGF-beta level [ Time Frame: 2-3 years ]
  3. IL-10 levels [ Time Frame: 2-3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872219


Contacts
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Contact: Aki Sinkkonen 358 2941 20315 aki.sinkkonen@helsinki.fi
Contact: Riikka Puhakka 358 50 3199363 riikka.puhakka@helsinki.fi

Sponsors and Collaborators
Helsinki University
Tampere University
Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri)
Business Finland (National Innovation Agency)

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Responsible Party: Aki Sinkkonen, University Researcher, Helsinki University
ClinicalTrials.gov Identifier: NCT03872219     History of Changes
Other Study ID Numbers: HelsinkiUAdele2poc
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will share it according to Finnish legislation and ethical committee permission. The permission restrict sharing tightly.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aki Sinkkonen, Helsinki University:
biodiversity intervention
IgE
atopy
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases