The role of nutritional support with probiotics in outpatients with symptomatic acute respiratory tract infections: a multicenter, randomized, double-blind, placebo-controlled dietary study

{ 'indexed': {'date-parts': [[2024, 1, 5]], 'date-time': '2024-01-05T00:15:48Z', 'timestamp': 1704413748419}, 'reference-count': 58, 'publisher': 'Springer Science and Business Media LLC', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2024, 1, 4]], 'date-time': '2024-01-04T00:00:00Z', 'timestamp': 1704326400000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2024, 1, 4]], 'date-time': '2024-01-04T00:00:00Z', 'timestamp': 1704326400000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'funder': [ { 'name': 'Nordic Biotic Sp. z o.o.', 'award': [ '# DT0003A-COV', '# DT0003A-COV', '# DT0003A-COV', '# DT0003A-COV', '# DT0003A-COV', '# DT0003A-COV', '# DT0003A-COV']}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'abstract': '<jats:title>Abstract</jats:title><jats:sec>\n' ' <jats:title>Background</jats:title>\n' ' <jats:p>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.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>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 ' '(<jats:italic>Bifidobacterium (B.) lactis</jats:italic> BI040, <jats:italic>B. ' 'longum</jats:italic> BL020, <jats:italic>Lactobacillus (L) rhamnosus</jats:italic> LR110, ' '<jats:italic>L. casei</jats:italic> LC130, <jats:italic>L. acidophilus</jats:italic> 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 ' '<jats:italic>U</jats:italic> test.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>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), ' '<jats:italic>P</jats:italic>\u2009&lt;\u20090.05). The probiotic group had a shorter duration ' 'of fatigue and anxiety after COVID -19 (<jats:italic>P</jats:italic>\u2009&lt;\u20090.05) and ' 'a greater change in IgG concentration on RBD/S1 (225.9 vs. 105.6 binding antibody units/mL, ' '<jats:italic>P</jats:italic>\u2009&lt;\u20090.05).</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>Use of probiotics alleviates acute and post-disease symptoms, and ' 'improves humoral immune response to viral antigens.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Trial registration</jats:title>\n' ' <jats:p>Registered at clinicaltrials.gov as NCT04907877, June 1, ' '2021.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1186/s40795-023-00816-8', 'type': 'journal-article', 'created': {'date-parts': [[2024, 1, 4]], 'date-time': '2024-01-04T15:05:48Z', 'timestamp': 1704380748000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'The role of nutritional support with probiotics in outpatients with symptomatic acute ' 'respiratory tract infections: a multicenter, randomized, double-blind, placebo-controlled ' 'dietary study', 'prefix': '10.1186', 'volume': '10', 'author': [ {'given': 'Pavlo O.', 'family': 'Kolesnyk', 'sequence': 'first', 'affiliation': []}, {'given': 'Iryna H.', 'family': 'Paliy', 'sequence': 'additional', 'affiliation': []}, {'given': 'Larysa P.', 'family': 'Sydorchuk', 'sequence': 'additional', 'affiliation': []}, {'given': 'Zoriana P.', 'family': 'Hoda', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nataliya O.', 'family': 'Ivanchenko', 'sequence': 'additional', 'affiliation': []}, {'given': 'Oksana S.', 'family': 'Lych', 'sequence': 'additional', 'affiliation': []}, {'given': 'Natalia R.', 'family': 'Huley', 'sequence': 'additional', 'affiliation': []}, {'given': 'Oksana I.', 'family': 'Matsyura', 'sequence': 'additional', 'affiliation': []}, {'given': 'Zoryana L.', 'family': 'Slyuzar', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sergiy V.', 'family': 'Gerasymov', 'sequence': 'additional', 'affiliation': []}], 'member': '297', 'published-online': {'date-parts': [[2024, 1, 4]]}, 'reference': [ { 'key': '816_CR1', 'doi-asserted-by': 'publisher', 'first-page': '100986', 'DOI': '10.1016/j.eclinm.2021.100986', 'volume': '37', 'author': 'X Jin', 'year': '2021', 'unstructured': 'Jin X, Ren J, Li R, Gao Y, et al. 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Before enrollment in the study, eligible ' 'participants had protocol-specific health insurance and were familiarized with ' 'the study procedures. A signed informed consent was obtained from all patients. ' 'This study was registered at ClinicalTrials.gov on July 01, 2021 before the ' 'first patient signed the informed consent form (identifier: NCT04907877).', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethics approval and consent to participate'}}, { 'value': 'Not applicable.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent for publication'}}, { 'value': 'POK, IHP, LPS, ZРH, OSL, NRH received investigator fees; SVG received study ' 'management fee from Nordic Biotic Sp. z o.o. (Warsaw, Poland). NOI, OIM, ZLS ' 'reported no competing interests.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '4'}