Biodiversity Intervention and Atopic Sensitization (PREVALL)

University of Helsinki

Status: Not yet enrolling

Conditions: Atopy; Allergic Rhinitis; Allergy; Allergic Sensitisation

Treatments: Combination Product: Nature-based materials

Study type: Interventional

Funder types: Other

Identifiers

NCT03872219

HelsinkiUAdele2poc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: Under 1 month old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

350 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The children will receive and they are exposed daily to harmless materials that look and feel like the biodiversity intervention materials.

Treatment:

Combination Product: Nature-based materials

intervention arm

Experimental group

Description:

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

Treatment:

Combination Product: Nature-based materials