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| Name | Class |
|---|---|
| Allergologiepraktijk Arnhem/Radboud/Rijnstate | UNKNOWN |
| NIZO Food Research | OTHER |
| Wageningen University | OTHER |
| Campina Innovation |
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In vitro studies reveal immunomodulatory effects of probiotic bacteria that are strain-dependent. Differential immunomodulatory in vitro capacities can not be extrapolated directly to in vivo efficacy. Thus, in vitro screening should be followed by comparative analysis of the selected immunomodulatory probiotic strains in an in vivo setting. Birch pollen allergy is one of the most common forms of respiratory allergy in European countries, and recognized by a Th2-skewed immune system. Five Lactobacillus strains will be evaluated for their immunomodulatory properties in birch pollen sensitive subjects outside the hay fever season. A double-blind placebo-controlled parallel study will be performed in which subjects with a proven birch pollen allergy will consume one of 5 different probiotic yoghurts containing 4 L. plantarum strains and 1 L. casei strain or a placebo yoghurt. Blood samples are collected at the start and after 4 weeks. Immune parameters are determined in serum and peripheral blood mononuclear cell cultures (hPBMC) derived from these subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoghurt with Lactobacillus strain (L.plantarum WCFS1) | Experimental |
| |
| Yoghurt with Lactobacillus strain (L.plantarum NIZO3400) | Experimental |
| |
| Yoghurt with Lactobacillus strain (L. plantarum NIZO2877) | Experimental |
| |
| Yoghurt with Lactobacillus strain (L.plantarum CBS125632) | Experimental |
| |
| Yoghurt with Lactobacillus casei Shirota | Active Comparator |
| |
| Placebo Yoghurt | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoghurt with L. plantarum strain | Dietary Supplement | Intake of yoghurt during 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Il-13 in PBMC after ex-vivo stimulation with birch pollen allergen (Betv1) |
| Measure | Description | Time Frame |
|---|---|---|
| Other cytokines and cell-surface markers in PBMC ex vivo stimulation assay, birch pollen specific IgE, IgG and IgG4 in blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A Jansen, Drs | Allergologiepraktijk Arnhem/Radboud/Rijnstate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergologiepraktijk Arnhem/Radboud/Rijnstate | Arnhem | Gelderland | 6824 BJ | Netherlands |
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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 |
|---|---|
| D015014 | Yogurt |
| ID | Term |
|---|---|
| D043302 | Cultured Milk Products |
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
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| UNKNOWN |
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| Yoghurt with L.casei | Dietary Supplement | Intake of yoghurt during 4 weeks |
|
| Yoghurt with L. plantarum strain | Dietary Supplement | Intake of yoghurt during 4 weeks |
|
| Yoghurt with L. plantarum strain | Dietary Supplement | Yoghurt with L. plantarum strain |
|
| Yoghurt with L. plantarum strain | Dietary Supplement | Intake of yoghurt during 4 weeks |
|
| Yoghurt | Dietary Supplement | Intake of yoghurt during 4 weeks |
|
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010829 |
| Physiological Phenomena |
| D000074421 | Fermented Foods |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |