Probiotics for Birch Pollen Allergy

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

Probiotic Intervention for Children With Birch Pollen Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746226
• Other study ID #: Danisco - TBPA06
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 2, 2008
• Last updated: September 2, 2008
• Start date: March 2006
• Est. completion date: February 2007

Study information

• Verified date: September 2008
• Source: Danisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 10 Years

Eligibility

Inclusion Criteria:

Physician verified birch pollen allergy

Exclusion Criteria:

Diagnosed asthma Habitual use of probiotics and/or prebiotics

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• Lactobacillus acidophilus and Bifidobacterium lactis
Daily 5x10^9 CFU of a combination of L. acidophilus and B. lactis
• Placebo
Microcrystalline cellulose As capsule which could be opened

Locations

Country	Name	City	State
Finland	Turku University Central Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Danisco

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birch pollen allergy symptoms		March/April and June	No
Primary	Nasal Eosinophilia		April/May and June	No
Secondary	Change in microbiota composition		April/May and June	No
Secondary	Cytokine profile from serum		April/May and June	No
Secondary	Faecal recovery of administered probiotics		April/May and June	No