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

Not Applicable

Completed

Interventions: Dietary Supplement: Probiotic
Dietary Supplement: Maltodextrin

Brief Summary: 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: To identify immune markers in allergic individuals that are impacted by probiotic treatment during seasonal exposure

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	probiotic blended in maltodextrin
Placebo	Maltodextrin	maltodextrin powder

Primary Outcome Measures

Name	Time	Method
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)	0 (baseline), 1, and 2 months	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.
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)	0 (baseline), 1 and 2 months	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.

Secondary Outcome Measures

Name	Time	Method
Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)	Measures at baseline, 1, and 2 months	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.
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