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A live microbial consortium (OL-1) with bacteria containing potentially cross-reactive antigens (CRAGs) stimulates anti-SARS-CoV-2 immune responses in vitro\/vivo. We evaluated OL-1\u2019s efficacy in enhancing anti-SARS-CoV-2 immunity in unvaccinated, previously infected adults.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a pilot, parallel-group, triple-blind randomized controlled trial in 2021\u20132022 involving 52 generally healthy adults ages 18\u201360, unvaccinated against COVID-19, with SARS-CoV-2 infection\u2009\u2265\u20094 months prior. Participants received 21 days of either standard-dose OL-1, high-dose OL-1, or placebo. The primary outcome was change in plasma anti-SARS-CoV-2 IgG titers from baseline to Day 21. Secondary efficacy outcomes included changes through Day 42, interferon gamma (IFNg) release from stimulated peripheral blood mononuclear cells, and new SARS-CoV-2 infections. Safety was assessed through adverse events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Significant increases in plasma IgG levels were observed by Day 42 in the standard-dose OL-1 group (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200917) compared to placebo (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200918) (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.02). No significant changes were observed in the high-dose group (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200917). Marginal increases in IFNg release were observed in standard-dose recipients after stimulation with CD4+-specific CRAG and SARS-CoV-2 peptides and TLR7 ligands; only changes post-TLR7 ligand stimulation were significant. No new SARS-CoV-2 infections were detected. The most common adverse events overall were mild gastrointestinal symptoms; headaches were more frequent in OL-1 recipients.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The live microbial consortium OL-1 was well-tolerated and associated with slightly increased anti-SARS-CoV-2 IgG levels in previously infected, unvaccinated adults at standard, but not high, dosage. Further research should confirm these findings and their clinical implications in larger populations.<\/jats:p>\n                    <jats:p>This study was registered on ClinicalTrials.gov (NCT04847349) on April 14, 2021.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s15010-025-02697-4","type":"journal-article","created":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T16:37:37Z","timestamp":1764175057000},"page":"473-485","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Live microbials to boost Anti-SARS-CoV-2 immunity clinical trial (Live BASIC trial): a triple-blind randomized controlled trial"],"prefix":"10.1007","volume":"54","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1831-1339","authenticated-orcid":false,"given":"Daniel B.","family":"Horton","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rahul","family":"Ukey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abhilasha","family":"Madhvi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tracy","family":"Andrews","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veenat","family":"Parmar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nancy","family":"Reilly","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanna M.","family":"M\u00e4kel\u00e4","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan","family":"Peterson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leah","family":"Hustad","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gloriana","family":"Wong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emily S.","family":"Barrett","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natalie","family":"Bruiners","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey L.","family":"Carson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kylie","family":"Getz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Greenberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alicia","family":"Iizuka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason","family":"Roy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander W.","family":"Pastuszak","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Markus J.","family":"Lehtinen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin J.","family":"Blaser","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"suffix":"Jr.","given":"Reynold A.","family":"Panettieri","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Laura","family":"Gennaro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,11,26]]},"reference":[{"key":"2697_CR1","unstructured":"Centers for Disease Control and Prevention. 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