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

Société des Produits Nestlé (SPN)20 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Seasonal Allergic Rhinitis

Interventions

MaltodextrinDIETARY_SUPPLEMENT

maltodextrin powder

ProbioticDIETARY_SUPPLEMENT

probiotic blended in maltodextrin powder

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Metabolic Unit, Nestlé Research Center

Lausanne, Canton of Vaud, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 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)

Time frame: 0 (baseline), 1, and 2 months

Secondary Outcomes

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.

Time frame: 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

Time frame: 8 weeks

Data from ClinicalTrials.gov

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