Immune-modulatory Effect of Probiotic Strain on Grass Pollen Allergic Individuals

Study Overview
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Brief Summary
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The purpose of the current study is to evaluate the effect of administering a probiotic strain on allergic symptoms and immune parameters (Th-2 cytokines, effector cells) in seasonal allergic rhinitis subjects.

Detailed Description
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To identify immune markers in allergic individuals that are impacted by probiotic treatment during seasonal exposure

Official Title
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Immune-modulatory Effect of Candidate Probiotic Strain on Whole Blood Cells of Grass Pollen Allergic Individuals

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Dietary Supplement: Maltodextrin
* Dietary Supplement: Probiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed allergy (allergic rhinitis) to grass pollen > 1 year and positive SPT > 3mm wheal diameter to grass pollen. Age 20-65 years adults Body Mass Index 19- 29 (people in the normal and overweight range) Having obtained his/her informed consent. Exclusion Criteria: Anemia Family history of congenital immunodeficiency Regular consumption of immunosuppressive or anti-inflammatory treatment Under medication against allergy (e.g. anti histaminic) Avoid regular consumption of probiotic and other dietary nutritional interventions Have a high alcohol consumption (more than 1 drink/day) Consumption of illicit drugs Pregnancy Subject who cannot be expected to comply with the study procedures, including consuming the test products Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>maltodextrin powder | Dietary Supplement: Maltodextrin<br>* maltodextrin powder<br>|
| Active Comparator: Probiotic<br>probiotic blended in maltodextrin | Dietary Supplement: Probiotic<br>* probiotic blended in maltodextrin powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake) | A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines. | 0 (baseline), 1 and 2 months | 
| Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake) | A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines. | 0 (baseline), 1, and 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) | TNSS Questionnaire were distributed at every visit (1 questionnaire for every week). The scored questionnaire were collected at subsequent visits. The symptom scores for nasal congestion, runny nose, nasal itching and sneezing were expressed as weekly sums (scale 0-3 for each symptom). The TNSS was the weekly sum for all the symptoms (scale 0-12). The TNSS data were analyzed as both monthly averages (at V2 and V3 compared to baseline V1) and weekly TNSS scores. Monthly TNSS scores were calculated as average over the 4 weeks preceding the visits. The higher the score is, the worse the outcome is. | Measures at baseline, 1, and 2 months | 
| Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells |  | 8 weeks | 
| Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups |  | 8 weeks | 
| Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells |  | 8 weeks |