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Biodiversity Intervention and Atopic Sensitization

NCT03872219 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2019-03-13

No results posted yet for this study

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.

Conditions

  • Atopy
  • Allergy
  • Allergic Rhinitis
  • Allergic Sensitisation

Interventions

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.

Sponsors & Collaborators

  • Tampere University

    collaborator OTHER

  • Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri)

    collaborator UNKNOWN

  • Business Finland (National Innovation Agency)

    collaborator UNKNOWN

  • University of Helsinki

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2023-08-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03872219 on ClinicalTrials.gov