Effect Of Probiotic Lactobacillus Paracasei Lp-33 For The Management Of Rhinitis In People Sensitized To Allergens

Inclusion Criteria:

• Male and female subjects;

• Aged 18 to 60 years;

• People with nasal and ocular discomfort at least sensitized to grass pollen;

• Subject with PER allergy (persistent form) as defined by ARIA guidelines or with arecurrent history of seasonal allergic rhinitis documented by treatment intakes in hismedical dossier.

• Previous positive skin prick test or presence of specific serum IgE antibodies classII or above against timothy grass in the last 5 years. If no data are available, atest for detection of timothy grass specific serum IgE antibodies (Phadia CAP System)will be performed at the pre-inclusion visit;

• With RQLQ score ≥ 2;

• Subjects agree to stop consumption of probiotics (food or dietary supplementcontaining probiotics) and vitamins and/or minerals during the study (D-10/D-7 toD49). Female subjects with efficient contraception and asthmatic subjects (with a controlleddisease and without oral corticosteroid) can be included in the study. The baseline period prior to treatment with Lactobacillus paracasei LP-33 is 7 days. Onrecommendations of the consulted experts, Pr Bousquet and Pr Hamelmann, a wash-out periodof 3 additional days is recommended before baseline for subject using intranasalcorticosteroid before their inclusion. As a consequence, the baseline may be extended to 10days for these subjects In case the subject consumed an anti-H1 (other than Loratadine)before his (her) inclusion, he (she) will have to switch to Loratadine to be included.

Exclusion Criteria:

• Taking part in another clinical trial or being in the exclusion period of a previousclinical trial;

• Presenting a psychological incapability or having a bad comprehension of thelanguage (French or German according to the concerned country) to understand theinformation letter and then to sign the informed consent;

• Refusing to sign the informed consent;

• Adult under legal protection (guardianship, wardship) or deprived from his rightsfollowing administrative or judicial decision;

• Pregnant or breastfeeding women;

• Use of medication which could interfere with the study in the investigator'sopinion (antibiotics, etc…);

• Subject who does not agree to stop his/her consumption of dietary supplements andfoods containing probiotics and his/her supplementation of vitamins/mineralsduring the study (D-10/D-7 to D49).