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Clinical Trials/NCT00746226
NCT00746226CompletedPhase 1

Probiotic Intervention for Children With Birch Pollen Allergy

Danisco2 sites in 1 country47 target enrollmentStarted: March 1, 2006Last updated:
Conditions

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)

Investigators

Sponsor
Danisco
Sponsor Class
Industry

Study Sites (2)

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