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Probiotics for Birch Pollen Allergy

This study has been completed.
Sponsor:
Information provided by:
Danisco
ClinicalTrials.gov Identifier:
NCT00746226
First received: September 2, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

September 2, 2008
September 2, 2008
March 2006
June 2006   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Probiotics for Birch Pollen Allergy
Probiotic Intervention for Children With Birch Pollen Allergy

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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rhinitis, Allergic, Seasonal
  • Biological: Lactobacillus acidophilus and Bifidobacterium lactis
    Daily 5x10^9 CFU of a combination of L. acidophilus and B. lactis
  • Biological: Placebo

    Microcrystalline cellulose

    As capsule which could be opened
  • Active Comparator: A
    Numbers 509-513, 700-709 and 900-909 Probiotic combination of L. acidophilus and B. lactis
    Intervention: Biological: Lactobacillus acidophilus and Bifidobacterium lactis
  • Placebo Comparator: B

    Numbers 612-624 and 800-811

    Microcrystalline cellulose

    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
February 2007
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

Physician verified birch pollen allergy

Exclusion Criteria:

Diagnosed asthma Habitual use of probiotics and/or prebiotics
Both
2 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00746226
Danisco - TBPA06
No
E. Isolauri Professor, Turku University Central Hospital
Danisco
Not Provided
Study Chair: Arthur C Ouwehand, PhD Danisco
Danisco
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP