Probiotics for Birch Pollen Allergy - Tabular View

Tracking Information

First Received Date ^ICMJE

September 2, 2008

Last Updated Date

September 2, 2008

Start Date ^ICMJE

March 2006

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Probiotics for Birch Pollen Allergy

Official Title ^ICMJE

Probiotic Intervention for Children With Birch Pollen Allergy

Brief 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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Rhinitis, Allergic, Seasonal

Intervention ^ICMJE

Biological: Lactobacillus acidophilus and Bifidobacterium lactis
Biological: Placebo

Study Arms / Comparison Groups

Active Comparator: Numbers 509-513, 700-709 and 900-909 Probiotic combination of L. acidophilus and B. lactis
Placebo Comparator:
Numbers 612-624 and 800-811

Microcrystalline cellulose

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2007

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Physician verified birch pollen allergy

Exclusion Criteria:

Diagnosed asthma Habitual use of probiotics and/or prebiotics

Gender

Both

Ages

2 Years to 10 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT ID ^ICMJE

NCT00746226

Responsible Party

E. Isolauri Professor, Turku University Central Hospital

Study ID Numbers ^ICMJE

Danisco - TBPA06

Study Sponsor ^ICMJE

Danisco

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Arthur C Ouwehand, PhD

Danisco

Information Provided By

Danisco

Verification Date

September 2008

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