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Probiotics for Birch Pollen Allergy

NCT ID: NCT00746226

Last Updated: 2008-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-02-28

Brief Summary

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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

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Conditions

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Rhinitis, Allergic, Seasonal

Keywords

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birch pollen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Numbers 509-513, 700-709 and 900-909 Probiotic combination of L. acidophilus and B. lactis

Group Type ACTIVE_COMPARATOR

Lactobacillus acidophilus and Bifidobacterium lactis

Intervention Type BIOLOGICAL

Daily 5x10\^9 CFU of a combination of L. acidophilus and B. lactis

B

Numbers 612-624 and 800-811

Microcrystalline cellulose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Microcrystalline cellulose

As capsule which could be opened

Interventions

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Lactobacillus acidophilus and Bifidobacterium lactis

Daily 5x10\^9 CFU of a combination of L. acidophilus and B. lactis

Intervention Type BIOLOGICAL

Placebo

Microcrystalline cellulose

As capsule which could be opened

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Physician verified birch pollen allergy

Exclusion Criteria

Diagnosed asthma Habitual use of probiotics and/or prebiotics
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danisco

INDUSTRY

Sponsor Role lead

Responsible Party

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Turku University Central Hospital

Principal Investigators

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Arthur C Ouwehand, PhD

Role: STUDY_CHAIR

Danisco

Locations

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Turku University Central Hospital

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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Danisco - TBPA06

Identifier Type: -

Identifier Source: org_study_id