Efficacy and safety of the probiotic Lactobacillus paracasei LP-33 in allergic rhinitis: a double-blind, randomized, placebo-controlled trial (GA2LEN Study)

• Published in: European journal of clinical nutrition 2014-05, Vol.68 (5), p.602-607
• Main Authors: Costa, D J, Marteau, P, Amouyal, M, Poulsen, L K, Hamelmann, E, Cazaubiel, M, Housez, B, Leuillet, S, Stavnsbjerg, M, Molimard, P, Courau, S, Bousquet, J
• Format: Article
• Language: English
• Subjects: 631/154/109; 692/699/249/2510/9; 692/700/459/1994; Adult; Allergic rhinitis; Allergies; Antihistamines; Biological and medical sciences; Care and treatment; Clinical Nutrition; Confidence intervals; Diagnosis; Dietary Supplements; Double-Blind Method; Double-blind studies; Endpoint Determination; Epidemiology; Feeding. Feeding behavior; Female; Fundamental and applied biological sciences. Psychology; Genetic aspects; Grasses; Hay-fever; Helper cells; Histamine Antagonists - pharmacology; Humans; Immunoglobulin E; Internal Medicine; Lactobacilli; Lactobacillus; Lactobacillus paracasei; Loratadine - therapeutic use; Lymphocytes T; Male; Medical sciences; Medicine; Medicine & Public Health; Metabolic Diseases; Middle Aged; Non tumoral diseases; original-article; Otorhinolaryngology. Stomatology; Patient Compliance; Physiological aspects; Placebos; Pollen; Pollen - adverse effects; Pollen - immunology; Probiotics; Probiotics - administration & dosage; Public Health; Quality of Life; Rhinitis; Rhinitis, Allergic, Seasonal - drug therapy; Rhinitis, Allergic, Seasonal - immunology; Rhinitis, Allergic, Seasonal - therapy; Seasons; Skin tests; Treatment Outcome; Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology; Vertebrates: anatomy and physiology, studies on body, several organs or systems
• ISSN: 0954-3007; 1476-5640
• DOI: 10.1038/ejcn.2014.13

Background/objectives: An imbalance between Th1 and Th2 cells is involved in allergic rhinitis (AR) that may be improved by probiotics. To test the efficacy of the probiotic Lactobacillus paracasei subsp. paracasei LP-33, a double-blind, placebo-controlled, randomized trial was carried out in patients with AR to grass pollen treated with loratadine and presenting altered quality of life. Subjects/methods: Subjects with persistent AR, symptomatic during the grass pollen season, and a positive skin test or specific immunoglobulin E to grass pollens were included by general practitioners (GPs). All received loratadine for 5 weeks. The primary end point was the improvement in Rhinitis Quality of Life (RQLQ) global score at the fifth week of LP-33 consumption compared with placebo (in addition to loratadine). Secondary end points included nasal and ocular symptoms (individual and total symptom scores), visual analogue scale and time of first exacerbation of the symptoms when loratadine was stopped. Results: A total of 425 subjects were included. Using intent-to-treat analysis, the RQLQ global score decreased significantly more in the LP-33 group than in the placebo group ( P =0.0255, difference=−0.286 (95% confidence interval (CI): −0.536; −0.035)). No significant differences were noted for the change of the rhinitis total symptom score 5 global score between groups ( P =0.1288, difference=−0.452 (95% CI: −1.036; 0.132)). Significant differences in ocular symptoms (RQLQ) were observed between groups ( P =0.0029, difference=−0.4087 (95% CI: −0.6768; −0.1407)). Conclusions: This study performed by GPs shows that LP-33 improves the quality of life of subjects with persistent AR who are currently being treated with an oral H 1 -antihistamine. Whereas nasal symptoms had not changed, ocular symptoms had consistently improved.