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OpenTrials
Completed

NCT Number: NCT00746226

Probiotics for 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.

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Key information

Conditions

Rhinitis, Allergic, Seasonal Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Turku University Central Hospital

Turku, 20250, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Physician verified birch pollen allergy

Exclusion criteria

Diagnosed asthma Habitual use of probiotics and/or prebiotics

Treatment and study plan

Lactobacillus acidophilus and Bifidobacterium lactis

Biological

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

Placebo

Biological

Microcrystalline cellulose

As capsule which could be opened

Primary outcomes

  1. Birch pollen allergy symptoms

    Time frame: March/April and June

  2. Nasal Eosinophilia

    Time frame: April/May and June

Secondary outcomes

  1. Change in microbiota composition

    Time frame: April/May and June

  2. Cytokine profile from serum

    Time frame: April/May and June

  3. Faecal recovery of administered probiotics

    Time frame: April/May and June

Sponsors and collaborators

Lead sponsor

Danisco

Industry

Registry information

Official study title

Probiotic Intervention for Children With Birch Pollen Allergy

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Sep 3, 2008
Registry last updated
Sep 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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