Probiotics for Birch Pollen Allergy

September 2, 2008 updated by: Danisco

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20250
        • Turku University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Physician verified birch pollen allergy

Exclusion Criteria:

Diagnosed asthma Habitual use of probiotics and/or prebiotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Birch pollen allergy symptoms
Time Frame: March/April and June
March/April and June
Nasal Eosinophilia
Time Frame: April/May and June
April/May and June

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in microbiota composition
Time Frame: April/May and June
April/May and June
Cytokine profile from serum
Time Frame: April/May and June
April/May and June
Faecal recovery of administered probiotics
Time Frame: April/May and June
April/May and June

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danisco

Investigators

  • Study Chair: Arthur C Ouwehand, PhD, Danisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Estimate)

September 3, 2008

Last Update Submitted That Met QC Criteria

September 2, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Danisco - TBPA06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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