PMID- 33376575 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220419 IS - 1939-4551 (Print) IS - 1939-4551 (Electronic) IS - 1939-4551 (Linking) VI - 14 IP - 1 DP - 2021 Jan TI - First evaluation of a symbiotic food supplement in an allergen exposure chamber in birch pollen allergic patients. PG - 100494 LID - 10.1016/j.waojou.2020.100494 [doi] LID - 100494 AB - BACKGROUND: Allergic rhinitis/rhinoconjunctivitis is the most common immune disease worldwide, but still largely underestimated, underdiagnosed, and undertreated. Dysbiosis and reduced microbial diversity is linked to the development of allergies, and the immunomodulatory effects of pro- and prebiotics might be used to counteract microbiome dysbiosis in allergy. Adequate symbiotic (multi-strain pro-, plus prebiotic) supplementation can be suggested as a complementary approach in the management of allergic rhinitis. OBJECTIVE: The effects of the daily intake of a symbiotic food supplement (combination of Lactobacillus acidophilus NCFM and Bifidobacterium lactis BL-04 with Fructo-Oligosaccharides) for 4 months in birch pollen allergic rhinoconjunctivitis patients were investigated for the first time in an allergen exposure chamber (AEC) allowing standardised, reproducible pollen exposure before and after intake. METHODS: Eligible patients were exposed to birch pollen (8000 pollen/m(3) for 120 min) at the GA(2)LEN AEC, at baseline (V1) and final visit (V3) outside the season. The Total Symptom Score (TSS) and the scores for nose, eye, bronchial system, and others were evaluated every 10 min during exposure. Other secondary endpoints were the changes in well-being, Peak Nasal Inspiratory Flow (PNIF), lung function parameters, and safety. Co-primary endpoints were differences in Total Nasal Symptom Score (TNSS) and TSS after 120 min of exposure between both visits. Temporal evolution of symptom scores were analysed in an exploratory way using linear mixed effects models. RESULTS: 27 patients (mean age 45 years, 15% male) completed the study. Both co-primary endpoints showed significant improvement after intake of the symbiotic. Median TNSS and TSS were decreased 50% and 80% at 120 min (adjusted p-value = 0.025 and p < 0.01 respectively).All four symptom scores and the personal well-being, improved to a clinically relevant extent over time, visible by a weaker increase in symptoms during 120 min of the final birch pollen exposure. No relevant differences were observed for PNIF, PEF, and spirometry. There were no airway obstructions or lung restrictions before and after both exposures. Late phase reactions after exposure were reduced after V3, documenting a better birch pollen tolerability of the patients. The safety and tolerability profile of the symbiotic food supplement was excellent, no adverse events (AEs) were observed. CONCLUSIONS: This first evaluation of a symbiotic food supplement in an AEC in rhinoconjunctivitis patients with or without asthma induced by birch pollen revealed a significant beneficial effect, harnessing significant improvements of symptoms and well-being while maintaining an excellent safety and tolerability profile. CI - (c) 2020 The Author(s). FAU - Bergmann, Karl-Christian AU - Bergmann KC AD - Department for Dermatology and Allergy, Charite - Universitatsmedizin Berlin, Corporate Member of Freie Universitat Berlin, Humboldt-Universitat zu Berlin, And Berlin Institute of Health, Berlin, Germany. AD - ECARF - European Centre for Allergy Research Foundation, Berlin, Germany. FAU - Krause, Linda AU - Krause L AD - Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg- Eppendorf, Hamburg, Germany. FAU - Hiller, Julia AU - Hiller J AD - Bencard Allergie GmbH, Munich, Germany. FAU - Becker, Sylvia AU - Becker S AD - ECARF - European Centre for Allergy Research Foundation, Berlin, Germany. FAU - Kugler, Sebastian AU - Kugler S AD - ECARF - European Centre for Allergy Research Foundation, Berlin, Germany. FAU - Tapparo, Martin AU - Tapparo M AD - Bencard Allergie GmbH, Munich, Germany. FAU - Pfaar, Oliver AU - Pfaar O AD - Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universitat Marburg, Marburg, Germany. FAU - Zuberbier, Torsten AU - Zuberbier T AD - Department for Dermatology and Allergy, Charite - Universitatsmedizin Berlin, Corporate Member of Freie Universitat Berlin, Humboldt-Universitat zu Berlin, And Berlin Institute of Health, Berlin, Germany. AD - ECARF - European Centre for Allergy Research Foundation, Berlin, Germany. FAU - Kramer, Matthias F AU - Kramer MF AD - Bencard Allergie GmbH, Munich, Germany. AD - Allergy Therapeutics (UK) Ltd, Worthing, UK. FAU - Guethoff, Sonja AU - Guethoff S AD - Bencard Allergie GmbH, Munich, Germany. FAU - Graessel, Anke AU - Graessel A AD - Bencard Allergie GmbH, Munich, Germany. AD - Allergy Therapeutics (UK) Ltd, Worthing, UK. LA - eng PT - Journal Article DEP - 20201218 PL - United States TA - World Allergy Organ J JT - The World Allergy Organization journal JID - 101481283 PMC - PMC7753943 OTO - NOTNLM OT - Allergen exposure chamber (AEC) OT - Birch pollen allergy OT - Food supplement OT - Peak expiratory flow (PEFBackspace) OT - Peak nasal inspiratory flow (PNIF) OT - Probiotic OT - Symbiotic OT - Total symptom score (TSS) COIS- JH, MT, MFK, SG, and AG are employees of Allergy Therapeutics / Bencard Allergie GmbH. Ms. Becker, Dr. Krause and Mr. Kugler have nothing to disclose. Prof. Bergmann reports personal fees for Lectures: ALK, AstraZeneca, Allergopharma, Almirall, Bencard, Chiesi, GSK, HAL, LETI, Lofarma, Mundipharma, Novartis, Sanofi. Non-financial support as Chair of German Pollen Information Service Foundation, personal fees and non-financial support from Consultant physician for ECARF, personal fees and non-financial support from Advisory Board member of AstraZeneca, ECARF, GSK, Robert-Koch-Institute Berlin (Vice chairman Public Health), Sanofi, outside the submitted work. Prof. Pfaar reports grants and personal fees from ALK-Abello, grants and personal fees from Allergopharma, grants and personal fees from Stallergenes Greer, grants and personal fees from HAL Allergy Holding B.V./HAL Allergie GmbH, grants and personal fees from Bencard Allergie GmbH/Allergy Therapeutics, grants and personal fees from Lofarma, grants from Biomay, grants from Circassia, grants and personal fees from ASIT Biotech Tools S.A., grants and personal fees from Laboratorios LETI/LETI Pharma, personal fees from MEDA Pharma/MYLAN, grants and personal fees from Anergis S.A., personal fees from Mobile Chamber Experts (a GA2LEN Partner), personal fees from Indoor Biotechnologies, grants from Glaxo Smith Kline, personal fees from Astellas Pharma Global, personal fees from EUFOREA, personal fees from ROXALL, personal fees from NOVARTIS, personal fees from SANOFI AVENTIS, personal fees from Med Update Europe GmbH, personal fees from streamedup! GmbH, outside the submitted work. Prof. Zuberbier reports personal fees from Bayer Health Care, FAES, Novartis, Henkel, and AstraZeneca. He received fees for talks and personal fees from AbbVie, ALK, Almirall, Astellas, Bayer Health Care Fee, Bencard Allergie GmbH, Berlin Chemie, HAL, Leti, Meda, Menarini, Merck, MSD, Novartis, Pfizer, Sanofi, Stallergenes, Takeda, Teva, UCB Henkel, Kryolan, L'Oreal outside the submitted work. The other authors declare that there are no competing interests. EDAT- 2020/12/31 06:00 MHDA- 2020/12/31 06:01 PMCR- 2020/12/18 CRDT- 2020/12/30 05:21 PHST- 2020/08/11 00:00 [received] PHST- 2020/10/16 00:00 [revised] PHST- 2020/11/16 00:00 [accepted] PHST- 2020/12/30 05:21 [entrez] PHST- 2020/12/31 06:00 [pubmed] PHST- 2020/12/31 06:01 [medline] PHST- 2020/12/18 00:00 [pmc-release] AID - S1939-4551(20)30397-5 [pii] AID - 100494 [pii] AID - 10.1016/j.waojou.2020.100494 [doi] PST - epublish SO - World Allergy Organ J. 2020 Dec 18;14(1):100494. doi: 10.1016/j.waojou.2020.100494. eCollection 2021 Jan.