Probiotic Intervention for Children With Birch Pollen Allergy
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 47
- Locations
- 2
- Primary Endpoint
- Birch pollen allergy symptoms
Study Overview
Brief Summary
Birch pollen allergy is one of the most common forms of respiratory allergy in the Nordic countries. Treatment consists of antihistamine use. Specific probiotic strains have been observed to modulate the immune system. Since the body has a common mucosal immune system; it was hypothesised that consumption of probiotics may affect also the respiratory mucosal immune response and hence affect respiratory allergy.
Earlier studies with probiotics had been unable to show improvements in adults with pollen allergy. It was therefore hypothesised that children, who's immune system is not yet fully developed, might be better targets.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Physician verified birch pollen allergy
Exclusion Criteria
- •Diagnosed asthma Habitual use of probiotics and/or prebiotics
Outcomes
Primary Outcomes
Birch pollen allergy symptoms
Time Frame: March/April and June
Nasal Eosinophilia
Time Frame: April/May and June
Secondary Outcomes
- Change in microbiota composition(April/May and June)
- Cytokine profile from serum(April/May and June)
- Faecal recovery of administered probiotics(April/May and June)
