Biodiversity Intervention and Atopic Sensitization (PREVALL)

March 11, 2019 updated by: Aki Sinkkonen, University of Helsinki

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IgE sensitization
Time Frame: 2-3 years
IgE sentitization is expected to be lower in the intervention arm than in the placebo arm.
2-3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Allergic symptoms
Time Frame: 2-3 years
All possible allergic symptomes, including atopy, will be estimated
2-3 years

Other Outcome Measures

Outcome Measure
Time Frame
IL-10: IL-17 ratio
Time Frame: 2-3 years
2-3 years
TGF-beta level
Time Frame: 2-3 years
2-3 years
IL-10 levels
Time Frame: 2-3 years
2-3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Tampere University
Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri)
Business Finland (National Innovation Agency)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 25, 2019

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HelsinkiUAdele2poc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will share it according to Finnish legislation and ethical committee permission. The permission restrict sharing tightly.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allergy

Clinical Trials on Nature-based materials

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe