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Probiotics for Birch Pollen Allergy

Primary Purpose

Rhinitis, Allergic, Seasonal

Status

Completed

Phase

Phase 1

Locations

Finland

Study Type

Interventional

Intervention

Lactobacillus acidophilus and Bifidobacterium lactis

Placebo

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring birch pollen

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Physician verified birch pollen allergy

Exclusion Criteria:

Diagnosed asthma Habitual use of probiotics and/or prebiotics

Sites / Locations

Turku University Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

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

Numbers 612-624 and 800-811 Microcrystalline cellulose

Outcomes

Primary Outcome Measures

Birch pollen allergy symptoms

Nasal Eosinophilia

Secondary Outcome Measures

Change in microbiota composition

Cytokine profile from serum

Faecal recovery of administered probiotics

Full Information

NCT ID

NCT00746226

First Posted

September 2, 2008

Last Updated

September 2, 2008

Sponsor

Danisco

1. Study Identification

Unique Protocol Identification Number

NCT00746226

Brief Title

Probiotics for Birch Pollen Allergy

Official Title

Probiotic Intervention for Children With Birch Pollen Allergy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Danisco

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis, Allergic, Seasonal

Keywords

birch pollen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

Numbers 612-624 and 800-811 Microcrystalline cellulose

Intervention Type

Biological

Intervention Name(s)

Lactobacillus acidophilus and Bifidobacterium lactis

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Microcrystalline cellulose As capsule which could be opened

Primary Outcome Measure Information:

Title

Birch pollen allergy symptoms

Time Frame

March/April and June

Title

Nasal Eosinophilia

Time Frame

April/May and June

Secondary Outcome Measure Information:

Title

Change in microbiota composition

Time Frame

April/May and June

Title

Cytokine profile from serum

Time Frame

April/May and June

Title

Faecal recovery of administered probiotics

Time Frame

April/May and June

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Physician verified birch pollen allergy Exclusion Criteria: Diagnosed asthma Habitual use of probiotics and/or prebiotics

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arthur C Ouwehand, PhD

Organizational Affiliation

Danisco

Official's Role

Study Chair

Facility Information:

Facility Name

Turku University Central Hospital

City

Turku

ZIP/Postal Code

20250

Country

Finland

12. IPD Sharing Statement

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Probiotics for Birch Pollen Allergy

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