The role of nutritional support with probiotics in outpatients with symptomatic acute respiratory tract infections: a multicenter, randomized, double-blind, placebo-controlled dietary study
Pavlo O Kolesnyk, Iryna H Paliy, Larysa P Sydorchuk, Zoriana P Hoda, Nataliya O Ivanchenko, Oksana S Lych, Natalia R Huley, Oksana I Matsyura, Zoryana L Slyuzar, Sergiy V Gerasymov
BMC Nutrition, doi:10.1186/s40795-023-00816-8
Background A number of laboratory data and clinical studies have shown that probiotic bacteria may be beneficial in respiratory viral diseases. We investigated the role of probiotics in coronavirus disease-19 (COVID -19), post-disease symptoms, and humoral immune responses to viral antigens. Methods This was a randomized, double-blind, placebo-controlled, prospective, multicenter study. We included symptomatic patients aged 18-65 years without risk of severe disease, and positive antigen/PCR test for SARS-CoV-2. Patients received (Bifidobacterium (B.) lactis BI040, B. longum BL020, Lactobacillus (L) rhamnosus LR110, L. casei LC130, L. acidophilus LA120, 5 billion CFU total) or placebo 1 capsule a day for 28 days and recorded symptoms. Three months later patients completed Post-COVID-19 Questionnaire (PCQ-19). On days 0-5 and 28-35, blood was sampled for IgG to nucleocapsid protein (NCP) and receptor binding domain (RBD)/spike 1 (S1) protein. The primary outcome measure was a patient global symptom score on day 10 of observation. The difference between groups was assessed using the Mann-Whitney U test.
Results Seventy-three patients were assessed for clinical endpoints and 44 patients were evaluated for antibody production. At day 10, the median global symptom score (interquartile range) was lower in the probiotic group (0.0 (0.0-2.0) vs. 2.0 (1.0-5.0), P < 0.05). The probiotic group had a shorter duration of fatigue and anxiety after COVID -19 (P < 0.05) and a greater change in IgG concentration on RBD/S1 (225.9 vs. 105.6 binding antibody units/mL, P < 0.05). Conclusions Use of probiotics alleviates acute and post-disease symptoms, and improves humoral immune response to viral antigens.
Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1186/ s40795-023-00816-8. Additional file 1: Supplemental Table 1 . The Post-COVID-19 Questionnaire and Post-COVID-19 Functional Scale data after a 3-month follow-up.
Authors' contributions POK, IHP, LPS, ZРH, OSL, NRH were responsible for the patient enrollment, data collection and reviewing the report. NOI, ZLS, OIM were responsible for the data collection and reviewing the report. SVG was responsible for designing and writing the protocol, extracting and analyzing data, interpreting results, creating tables and figures, writing the report.
Funding The study was sponsored by Nordic Biotic Sp. z o.o. (Warsaw, Poland). The sponsor was not involved in the study hypothesis/design, implementation, analysis, and interpretation. The funding was transparent, acknowledged, and appropriately recognized throughout all stages of study. The study was conducted in a full academic independence to report and publish all the findings.
Availability of data and materials The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Declarations Ethics approval and consent to participate Approvals were obtained from ethical committees at all study sites (Lviv Oblast Center for Disease Control and Prevention Ministry of Health of Ukraine, protocol #2 of 20 Apr 2021; Lviv Municipal Non-Profit Enterprise Third..
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