Probiotics for Birch Pollen Allergy

This study has been completed.
Information provided by:
Danisco Identifier:
First received: September 2, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

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.

Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Biological: Lactobacillus acidophilus and Bifidobacterium lactis
Biological: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Probiotic Intervention for Children With Birch Pollen Allergy

Resource links provided by NLM:

Further study details as provided by Danisco:

Primary Outcome Measures:
  • Birch pollen allergy symptoms [ Time Frame: March/April and June ] [ Designated as safety issue: No ]
  • Nasal Eosinophilia [ Time Frame: April/May and June ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in microbiota composition [ Time Frame: April/May and June ] [ Designated as safety issue: No ]
  • Cytokine profile from serum [ Time Frame: April/May and June ] [ Designated as safety issue: No ]
  • Faecal recovery of administered probiotics [ Time Frame: April/May and June ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: March 2006
Study Completion Date: February 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Numbers 509-513, 700-709 and 900-909 Probiotic combination of L. acidophilus and B. lactis
Biological: Lactobacillus acidophilus and Bifidobacterium lactis
Daily 5x10^9 CFU of a combination of L. acidophilus and B. lactis
Placebo Comparator: B

Numbers 612-624 and 800-811

Microcrystalline cellulose

Biological: Placebo

Microcrystalline cellulose

As capsule which could be opened


Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Physician verified birch pollen allergy

Exclusion Criteria:

Diagnosed asthma Habitual use of probiotics and/or prebiotics

  Contacts and Locations
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Please refer to this study by its identifier: NCT00746226

Turku University Central Hospital
Turku, Finland, 20250
Sponsors and Collaborators
Study Chair: Arthur C Ouwehand, PhD Danisco
  More Information

Responsible Party: E. Isolauri Professor, Turku University Central Hospital Identifier: NCT00746226     History of Changes
Other Study ID Numbers: Danisco - TBPA06 
Study First Received: September 2, 2008
Last Updated: September 2, 2008
Health Authority: Finland: Ethics Committee

Keywords provided by Danisco:
birch pollen

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Rhinitis processed this record on April 27, 2016