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

Volumn 68, Issue 5, 2014, Pages 602-607

  Costa, D J ^a   Marteau, P ^b   Amouyal, M ^a   Poulsen, L K ^c   Hamelmann, E ^d   Cazaubiel, M ^e   Housez, B ^e   Leuillet, S ^e   Stavnsbjerg, M ^f   Molimard, P ^g   Courau, S ^g   Bousquet, J ^h,i  

^a UNIV MONTPELLIER   (France)

^b UNIVERSITÉ PARIS DESCARTES   (France)

^c GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^d RUHR UNIVERSITY BOCHUM   (Germany)

^e Biofortis Mérieux NutriSciences Company   (France)

^f CHR HANSEN A S   (Denmark)

^g Merck Consumer Health Merck Médication Familiale   (France)

^h HÔPITAL ARNAUD DE VILLENEUVE   (France)

ⁱ CENTRE FOR RESEARCH IN EPIDEMIOLOGY AND POPULATION HEALTH   (France)

Author keywords

[No Author keywords available]

Indexed keywords

LORATADINE; PLACEBO; PROBIOTIC AGENT; ANTIHISTAMINIC AGENT;

ACUTE APPENDICITIS; ADULT; ALLERGIC RHINITIS; ARTICLE; BACTERIAL STRAIN; CONFIDENCE INTERVAL; CONTROLLED STUDY; DISEASE CLASSIFICATION; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; GOOD CLINICAL PRACTICE; GRASS POLLEN; HUMAN; HUMEROSCAPULAR PERIARTHRITIS; LACTOBACILLUS PARACASEI; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; OUTCOME ASSESSMENT; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; VISUAL ANALOG SCALE; YOUNG ADULT; BIOASSAY; CLINICAL TRIAL; DIET SUPPLEMENTATION; IMMUNOLOGY; INTERVENTION STUDY; LACTOBACILLUS; PATIENT COMPLIANCE; POLLEN; RHINITIS, ALLERGIC, SEASONAL; SEASON; TREATMENT OUTCOME;

LACTOBACILLUS PARACASEI; LACTOBACILLUS PARACASEI SUBSP. PARACASEI;

ADULT; DIETARY SUPPLEMENTS; DOUBLE-BLIND METHOD; ENDPOINT DETERMINATION; FEMALE; HISTAMINE ANTAGONISTS; HUMANS; INTERVENTION STUDIES; LACTOBACILLUS; LORATADINE; MALE; MIDDLE AGED; PATIENT COMPLIANCE; POLLEN; PROBIOTICS; QUALITY OF LIFE; RHINITIS, ALLERGIC, SEASONAL; SEASONS; TREATMENT OUTCOME;

EID: 84899968514     PISSN: 09543007     EISSN: 14765640     Source Type: Journal    
DOI: 10.1038/ejcn.2014.13     Document Type: Article

References (47)

1. Bousquet J, Khaltaev N, Cruz AA, Den burg J, Fokkens WJ, Togias A et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy 2008; 63(Suppl 86): 8-160
2. Bousquet J, Bachert C, Canonica GW, Casale TB, Cruz AA, Lockey RJ et al. Unmet needs in severe chronic upper airway disease (SCUAD). J Allergy Clin Immunol 2009; 124: 428-433
3. Canonica GW, Bousquet J, Mullol J, Scadding GK, Virchow JC. A survey of the burden of allergic rhinitis in Europe. Allergy 2007; 62(Suppl 85): 17-25
4. Schatz M. A survey of the burden of allergic rhinitis in the USA. Allergy 2007; 62(Suppl 85): 9-16
5. Valovirta E, Ryan D. Patient adherence to allergic rhinitis treatment: Results from patient surveys. Medscape J Med 2008; 10: 247
6. Virchow JC, Kay S, Demoly P, Mullol J, Canonica W, Higgins V. Impact of ocular symptoms on quality of life (QoL), work productivity and resource utilisation in allergic rhinitis patients-An observational, cross sectional study in four countries in Europe. J Med Econ 2011; 14: 305-314
7. Hakansson A, Molin G. Gut microbiota and inflammation. Nutrients 2011; 3: 637-682
8. Morita H, He F, Kawase M, Kubota A, Hiramatsu M, Kurisaki J et al. Preliminary human study for possible alteration of serum immunoglobulin E production in perennial allergic rhinitis with fermented milk prepared with Lactobacillus gasseri TMC0356. Microbiol Immunol 2006; 50: 701-706
9. Ciprandi G, Vizzaccaro A, Cirillo I, Tosca MA. Bacillus clausii exerts immunomodulatory activity in allergic subjects: A pilot study. Eur Ann Allergy Clin Immunol 2005; 37: 129-134
10. Food and Agriculture Organization and World Health Organization expert consulation. Consultation of Health and Nutritional Properties of Powder Milk and Live Lactic Acid Bacteria. Cordoba, Argentina. http://www.who.int/ foodsafety/ publications/fs-management/en/probiotics.pdf 2001
11. Magrone T, Jirillo E. The interplay between the gut immune system and microbiota in health and disease: Nutraceutical intervention for restoring homeostasis. Curr Pharm Des 2013; 19: 1329-1342
12. Singh A, Hacini-Rachinel F, Gosoniu ML, Bourdeau T, Holvoet S, Doucet-Ladeveze R et al. Immune-modulatory effect of probiotic Bifidobacterium lactis NCC2818 in individual suffering from seasonal allergic rhinitis to grass pollen: An exploratory, randomized, placebo-controlled clinical trial. Eur J Clin Nutr 2013; 67: 161-167
13. Pochard P, Gosset P, Grangette C, Andre C, Tonnel AB, Pestel J et al. Lactic acid bacteria inhibit TH2 cytokine production by mononuclear cells from allergic patients. J Allergy Clin Immunol 2002; 110: 617-623
14. Ghadimi D, Folster-Holst R, De Vrese M, Winkler P, Heller KJ, Schrezenmeir J. Effects of probiotic bacteria and their genomic DNA on TH1/TH2-cytokine production by peripheral blood mononuclear cells (PBMCs) of healthy and allergic subjects. Immunobiology 2008; 213: 677-692
15. von Mutius E. A fascinating look at the world with a new microscope. J Allergy Clin Immunol 2012; 129: 1202-1203
16. Jensen MP, Meldrum S, Taylor AL, Dunstan JA, Prescott SL. Early probiotic supplementation for allergy prevention: Long-Term outcomes. J Allergy Clin Immunol 2012; 130: 1209-1211
17. Prescott S, Nowak-Wegrzyn A. Strategies to prevent or reduce allergic disease. Ann Nutr Metab 2011; 59(Suppl 1): 28-42
18. Ivory K, Chambers SJ, Pin C, Prieto E, Arques JL, Nicoletti C. Oral delivery of Lactobacillus casei Shirota modifies allergen-induced immune responses in allergic rhinitis. Clin Exp Allergy 2008; 38: 1282-1289
19. Kawase M, He F, Kubota A, Hiramatsu M, Saito H, Ishii T et al. Effect of fermented milk prepared with two probiotic strains on Japanese cedar pollinosis in a doubleblind placebo-controlled clinical study. Int J Food Microbiol 2009; 128: 429-434
20. Ouwehand AC, Nermes M, Collado MC, Rautonen N, Salminen S, Isolauri E. Specific probiotics alleviate allergic rhinitis during the birch pollen season. World J Gastroenterol 2009; 15: 3261-3268
21. Kalliomaki M, Antoine JM, Herz U, Rijkers GT, Wells JM, Mercenier A. Guidance for substantiating the evidence for beneficial effects of probiotics: Prevention and management of allergic diseases by probiotics. J Nutr 2010; 140: 713S-721SS
22. Rijkers GT, Bengmark S, Enck P, Haller D, Herz U, Kalliomaki M et al. Guidance for substantiating the evidence for beneficial effects of probiotics: Current status and recommendations for future research. J Nutr 2010; 140: 671S-676SS
23. Vliagoftis H, Kouranos VD, Betsi GI, Falagas ME. Probiotics for the treatment of allergic rhinitis and asthma: Systematic review of randomized controlled trials. Ann Allergy Asthma Immunol 2008; 101: 570-579
24. Peng GC, Hsu CH. The efficacy and safety of heat-killed Lactobacillus paracasei for treatment of perennial allergic rhinitis induced by house-dust mite. Pediatr Allergy Immunol 2005; 16: 433-438
25. Wang MF, Lin HC, Wang YY, Hsu CH. Treatment of perennial allergic rhinitis with lactic acid bacteria. Pediatr Allergy Immunol 2004; 15: 152-158
26. Lin TY, Chen CJ, Chen LK, Wen SH, Jan RHA. Randomized prospective double blind controlled trial of the effect of probiotics on allergic rhinitis confined to Df, Dp or dust-sensitive children. Indian Pediatr 2013; 50: 209-213
27. Lue KH, Sun HL, Lu KH, Ku MS, Sheu JN, Chan CH et al. A trial of adding Lactobacillus johnsonii EM1 to levocetirizine for treatment of perennial allergic rhinitis in children aged 7-12 years. Int J Ped Otorhinolaryngol 2012; 76: 994-1001
28. Wassenberg J, Nutten S, Audran R, Barbier N, Aubert V, Moulin J et al. Effect of Lactobacillus paracasei ST11 on a nasal provocation test with grass pollen in allergic rhinitis. Clin Exp Allergy 2011; 41: 565-573
29. Snel J, Vissers YM, Smit BA, Jongen JM, van Der Meulen ET, Zwijsen R et al. Strain-specific immunomodulatory effects of Lactobacillus plantarum strains on birch-pollen-Allergic subjects out of season. Clin Exp Allergy 2011; 41: 232-242
30. Vissers YM, Snel J, Zuurendonk PF, Kleerebezem M, Wichers HJ, Savelkoul HF. Lactobacillus strains differentially modulate cytokine production by hPBMC from pollen-Allergic patients. FEMS Immunol Med Microbiol 2011; 61: 28-40
31. Juniper EF. Measuring health-related quality of life in rhinitis. J Allergy Clin Immunol 1997; 99: S742-S749
32. Bousquet J, Bachert C, Canonica GW, Mullol J, Van Cauwenberge P, Bindslev Jensen C et al. Efficacy of desloratadine in intermittent allergic rhinitis: A GALEN study. Allergy 2009; 64: 1516-1523
33. Bousquet J, Bachert C, Canonica GW, Mullol J, Van Cauwenberge P, Jensen CB et al. Efficacy of desloratadine in persistent allergic rhinitis-A GA(2)LEN study. Int Arch Allergy Immunology 2010; 153: 395-402
34. International Consensus Report on Diagnosis and Management of Rhinitis. International Rhinitis Management Working Group. Allergy 1994; 49(19 Suppl): 1-34
35. Bousquet J, Van Cauwenberge P, Khaltaev N. Allergic rhinitis and its impact on asthma. The J Allergy Clin Immunol 2001; 108(5 Suppl): S147-S334
36. Bachert C, Maspero J. Efficacy of second-generation antihistamines in patients with allergic rhinitis and comorbid asthma. J Asthma 2011; 48: 965-973
37. Babre D. Medical coding in clinical trials. Perspect Clin Res 2010; 1: 29-32
38. Bousquet PJ, Combescure C, Neukirch F, Klossek JM, Mechin H, Daures JP et al. Visual analog scales can assess the severity of rhinitis graded according to ARIA guidelines. Allergy 2007; 62: 367-372
39. Bousquet PJ, Fabbro-Peray P, Janin N, Annesi-Maesano I, Neukirch F, Daures JP et al. Pilot study assessing the impact of smoking on nasal-specific quality of life. Allergy 2004; 59: 1015-1016
40. Bousquet PJ, Combescure C, Klossek JM, Daures JP, Bousquet J. Change in visual analog scale score in a pragmatic randomized cluster trial of allergic rhinitis. J Allergy Clin Immunol 2009; 123: 1349-1354
41. Bousquet J, Bodez T, Gehano P, Klossek JM, Liard F, Neukirch F et al. Implementation of guidelines for allergic rhinitis in specialist practices. a randomized pragmatic controlled trial. Int Arch Allergy Immunol 2009; 150: 75-82
42. Ciprandi G, Canonica WG, Grosclaude M, Ostinelli J, Brazzola GG, Bousquet J. Effects of budesonide and fluticasone propionate in a placebo-controlled study on symptoms and quality of life in seasonal allergic rhinitis. Allergy 2002; 57: 586-591
43. Walter Canonica G, Bousquet J, Van Hammee G, Bachert C, Durham SR, Klimek L et al. Levocetirizine improves health-related quality of life and health status in persistent allergic rhinitis. Respir Med 2006; 100: 1706-1715
44. Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB et al. Allergic Rhinitis and its impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol 2010; 126: 466-476
45. Bachert C, Bousquet J, Canonica GW, Durham SR, Klimek L, Mullol J et al. Levocetirizine improves quality of life and reduces costs in long-Term management of persistent allergic rhinitis. J Allergy Clin Immunol 2004; 114: 838-844
46. Ciprandi G, Klersy C, Cirillo I, Marseglia GL. Quality of life in allergic rhinitis: Relationship with clinical, immunological, and functional aspects. Clin Exp Allergy 2007; 37: 1528-1535
47. Juniper EF, Guyatt GH, Willan A, Griffith LE. Determining a minimal important change in a disease-specific Quality of Life Questionnaire. J Clin Epidemiol 1994; 47: 81-87