Probiotics for Birch Pollen Allergy - Full Text View

Sponsor:	Danisco
Information provided by:	Danisco
ClinicalTrials.gov Identifier:	NCT00746226

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Probiotic Intervention for Children With Birch Pollen Allergy

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hay Fever

Drug Information available for: Lactobacillus acidophilus

U.S. FDA Resources

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
A: Active Comparator 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
B: Placebo Comparator 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

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

Keywords provided by Danisco:

birch pollen

Additional relevant MeSH terms:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Immune System Diseases
Respiratory Tract Diseases

Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Rhinitis
Nose Diseases
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 25, 2009