Probiotics for Birch Pollen Allergy

Danisco

Status and phase: Completed; Phase 2; Phase 1

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Biological: Lactobacillus acidophilus and Bifidobacterium lactis; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00746226

Danisco - TBPA06

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Physician verified birch pollen allergy

Exclusion criteria

Diagnosed asthma Habitual use of probiotics and/or prebiotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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47 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

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

Treatment:

Biological: Lactobacillus acidophilus and Bifidobacterium lactis

B

Placebo Comparator group

Description:

Numbers 612-624 and 800-811 Microcrystalline cellulose

Treatment:

Biological: Placebo