Probiotics for Birch Pollen Allergy

NCT00746226 | Completed Phase 1

• 1 other identifier: Danisco - TBPA06
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

birch pollen

Outcome Measures

Primary Outcomes (2)

• Birch pollen allergy symptoms

  March/April and June

• Nasal Eosinophilia

  April/May and June

Secondary Outcomes (3)

• Change in microbiota composition

  April/May and June

• Cytokine profile from serum

  April/May and June

• Faecal recovery of administered probiotics

  April/May and June

Study Arms (2)

A

ACTIVE COMPARATOR

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

Biological: Lactobacillus acidophilus and Bifidobacterium lactis

B

PLACEBO COMPARATOR

Numbers 612-624 and 800-811 Microcrystalline cellulose

Biological: Placebo

Interventions

Lactobacillus acidophilus and Bifidobacterium lactis BIOLOGICAL

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

A

Placebo BIOLOGICAL

Microcrystalline cellulose As capsule which could be opened

B

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Physician verified birch pollen allergy

You may not qualify if:

• Diagnosed asthma Habitual use of probiotics and/or prebiotics

Sponsors & Collaborators

• Danisco: lead

Study Sites (1)

Turku University Central Hospital

Turku, 20250, Finland

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Lacteol

Condition Hierarchy (Ancestors)

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

Study Officials

• Arthur C Ouwehand, PhD

  Danisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: March 1, 2006
• Primary Completion: June 1, 2006
• Study Completion: February 1, 2007
• Last Updated: September 3, 2008

Record last verified: 2008-09

Locations

FI (1)