Original Article | Published:

Food and health

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

European Journal of Clinical Nutrition volume 68, pages 602607 (2014) | Download Citation

Abstract

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 H1-antihistamine. Whereas nasal symptoms had not changed, ocular symptoms had consistently improved.

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Acknowledgements

BIOFORTIS managed all administrative and logistic procedures. The study was funded by Merck Medication Familiale and Chr Hansen A/S. The investigators who collaborated in this study.

Author information

Affiliations

  1. Primary Care Department, University of Medicine, Montpellier I University, Montpellier, France

    • D J Costa
    •  & M Amouyal
  2. University Paris Diderot, Sorbonne Paris Cité, APHP, Department of Hepato-gastro-enterology, Hôpital Lariboisière, Paris, France

    • P Marteau
  3. Allergy Clinic, Copenhagen University Hospital at Gentofte, Copenhagen, Denmark

    • L K Poulsen
  4. University Children’s Hospital, Ruhr-University Bochum, Department of Pediatrics, Bochum, Germany

    • E Hamelmann
  5. Biofortis, Mérieux NutriSciences Company, Saint-Herblain, France

    • M Cazaubiel
    • , B Housez
    •  & S Leuillet
  6. Global Regulatory and External Affairs, Chr. Hansen A/S, Hørsholm, Denmark

    • M Stavnsbjerg
  7. Merck Consumer Health, Merck Médication Familiale, Dijon, France

    • P Molimard
    •  & S Courau
  8. Department of Respiratory Diseases, University Hospital, Hôpital Arnaud de Villeneuve, Montpellier, France

    • J Bousquet
  9. Inserm, CESP Centre for Research in Epidemiology and Population Health, Respiratory and Environmental Epidemiology team, Villejuif, France

    • J Bousquet

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Competing interests

DJC received fees for consultancy from Merck Medication Familiale. PM received fees for consultancy, and lectures for Biocodex, Danone Merck Medication Familiale. LKP recieved fees for consultancy from Merck Medication Familiale. EH recieved fees for consultancy, and lectures for Milupa, Danone Merck Medication Familiale. MC, BH and SL are employees of Biofortis. MS is an employee of Chr. Hansen A/S. PM is an employee of Merck Medication Familiale. SC is an employee of Merck Medication Familiale. JB recieved fees for participation in scientific and advisory boards, giving lectures and press engagements from Actelion, Almirall, AstraZeneca, Chiesi, GlaxoSmithKline, Meda, Merck Sharpe & Dohme, Merck Medication Familiale Novartis, oM Pharma, Sanofi-Aventis, Schering Plough, Stallergènes, Takeda, Teva and Uriach. MA declares no conflict of interest.

Corresponding author

Correspondence to J Bousquet.

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DOI

https://doi.org/10.1038/ejcn.2014.13

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