Probiotics for Reduction Of Markers In Subjects With Allergy

Study Overview
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Brief Summary
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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.

Official Title
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Probiotics for Reduction Of Markers In Subjects With Allergy

Conditions
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Hay Fever, Birch Pollen Allergy

Intervention / Treatment
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* Dietary Supplement: Yoghurt with L. plantarum strain
* Dietary Supplement: Yoghurt with L.casei
* Dietary Supplement: Yoghurt with L. plantarum strain
* Dietary Supplement: Yoghurt with L. plantarum strain
* Dietary Supplement: Yoghurt with L. plantarum strain
* Dietary Supplement: Yoghurt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: birch pollen sensitive subjects Positive RAST or intracutane skintest age 18-50 signed informed consent form Exclusion Criteria: use of probiotics known allergy for pets (home setting) use of medication influencing the immune system use of antibiotics lactose intolerance pregnancy infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoghurt with Lactobacillus strain (L.plantarum WCFS1)<br> | Dietary Supplement: Yoghurt with L. plantarum strain<br>* Intake of yoghurt during 4 weeks<br>|
| Experimental: Yoghurt with Lactobacillus strain (L.plantarum NIZO3400)<br> | Dietary Supplement: Yoghurt with L. plantarum strain<br>* Intake of yoghurt during 4 weeks<br>|
| Experimental: Yoghurt with Lactobacillus strain (L. plantarum NIZO2877)<br> | Dietary Supplement: Yoghurt with L. plantarum strain<br>* Intake of yoghurt during 4 weeks<br>|
| Experimental: Yoghurt with Lactobacillus strain (L.plantarum CBS125632)<br> | Dietary Supplement: Yoghurt with L. plantarum strain<br>* Yoghurt with L. plantarum strain<br>|
| Active Comparator: Yoghurt with Lactobacillus casei Shirota<br> | Dietary Supplement: Yoghurt with L.casei<br>* Intake of yoghurt during 4 weeks<br>|
| Placebo Comparator: Placebo Yoghurt<br> | Dietary Supplement: Yoghurt<br>* Intake of yoghurt during 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Il-13 in PBMC after ex-vivo stimulation with birch pollen allergen (Betv1) |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  |