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

This is an interventional supportive care trial for Rhinitis focused on measuring Allergic rhinitis-Probiotic Lactobacillus paracasei LP-33- Read More

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 a recurrent history of seasonal allergic rhinitis documented by treatment intakes in his medical dossier.
• Previous positive skin prick test or presence of specific serum IgE antibodies class II or above against timothy grass in the last 5 years. If no data are available, a test 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 supplement containing probiotics) and vitamins and/or minerals during the study (D-10/D-7 to D49).

Female subjects with efficient contraception and asthmatic subjects (with a controlled disease and without oral corticosteroid) can be included in the study.

The baseline period prior to treatment with Lactobacillus paracasei LP-33 is 7 days. On recommendations of the consulted experts, Pr Bousquet and Pr Hamelmann, a wash-out period of 3 additional days is recommended before baseline for subject using intranasal corticosteroid before their inclusion. As a consequence, the baseline may be extended to 10 days 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 previous clinical trial;

  • Presenting a psychological incapability or having a bad comprehension of the language (French or German according to the concerned country) to understand the information letter and then to sign the informed consent;
  • Refusing to sign the informed consent;
  • Adult under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
  • Pregnant or breastfeeding women;
  • Use of medication which could interfere with the study in the investigator's opinion (antibiotics, etc…);
  • Subject who does not agree to stop his/her consumption of dietary supplements and foods containing probiotics and his/her supplementation of vitamins/minerals during the study (D-10/D-7 to D49).