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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Numbers 509-513, 700-709 and 900-909 Probiotic combination of L. acidophilus and B. lactis |
|
| B | Placebo Comparator | Numbers 612-624 and 800-811 Microcrystalline cellulose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus acidophilus and Bifidobacterium lactis | Biological | Daily 5x10^9 CFU of a combination of L. acidophilus and B. lactis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Birch pollen allergy symptoms | March/April and June | |
| Nasal Eosinophilia | April/May and June |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbiota composition | April/May and June | |
| Cytokine profile from serum | April/May and June | |
| Faecal recovery of administered probiotics |
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Inclusion Criteria:
Physician verified birch pollen allergy
Exclusion Criteria:
Diagnosed asthma Habitual use of probiotics and/or prebiotics
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| Name | Affiliation | Role |
|---|---|---|
| Arthur C Ouwehand, PhD | Danisco | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Central Hospital | Turku | 20250 | Finland |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
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| Placebo | Biological | Microcrystalline cellulose As capsule which could be opened |
|
| April/May and June |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |