Biodiversity Intervention and Atopic Sensitization

NCT03872219 | Unknown DMC

• 1 other identifier: HelsinkiUAdele2poc
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atopy; Allergy; Allergic Rhinitis; Allergic Sensitisation

Keywords

biodiversity intervention; IgE; atopy

Outcome Measures

Primary Outcomes (1)

• IgE sensitization

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

  2-3 years

Secondary Outcomes (1)

• Allergic symptoms

  2-3 years

Other Outcomes (3)

• IL-10: IL-17 ratio

  2-3 years

• TGF-beta level

  2-3 years

• IL-10 levels

  2-3 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

intervention arm

EXPERIMENTAL

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

Combination Product: Nature-based materials

Interventions

Nature-based materials COMBINATION_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.

Placebo; intervention arm

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• both parents have atopy
• newborn

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Helsinki: lead
• Tampere University: collaborator
• Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri): collaborator
• Business Finland (National Innovation Agency): collaborator

MeSH Terms

Conditions

Hypersensitivity; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate

Central Study Contacts

Aki Sinkkonen

CONTACT

358 2941 20315; aki.sinkkonen@helsinki.fi

Riikka Puhakka

CONTACT

358 50 3199363; riikka.puhakka@helsinki.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind randomized trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Researcher

Model Details: The study consists of two arms, the intervention arm and the placebo arm. Children are randomized into the arms.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: March 25, 2019
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2025
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share