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
  Purpose

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


  Eligibility

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

Inclusion Criteria:

Physician verified birch pollen allergy

Exclusion Criteria:

Diagnosed asthma Habitual use of probiotics and/or prebiotics

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746226

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

No publications provided

Responsible Party: E. Isolauri Professor, Turku University Central Hospital
ClinicalTrials.gov 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
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Rhinitis

ClinicalTrials.gov processed this record on October 20, 2014