Biodiversity Intervention and Atopic Sensitization

Allergic Rhinitis Clinical Trial

— PREVALL  

Official title:

The Effect of Plant and Soil-based Material on the Incidence of Atopic Sensitization

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03872219
• Other study ID #: HelsinkiUAdele2poc
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2019
• Source: Helsinki University
• Contact: Aki Sinkkonen
• Phone: 358 2941 20315
• Email: aki.sinkkonen[@]helsinki.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Allergic Sensitisation
• Allergy
• Atopy
• Rhinitis
• Rhinitis, Allergic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Helsinki University	Business Finland (National Innovation Agency), Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri), Tampere University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	IL-10: IL-17 ratio		2-3 years
Other	TGF-beta level		2-3 years
Other	IL-10 levels		2-3 years
Primary	IgE sensitization	IgE sentitization is expected to be lower in the intervention arm than in the placebo arm.	2-3 years
Secondary	Allergic symptoms	All possible allergic symptomes, including atopy, will be estimated	2-3 years