Live microbials to boost Anti-SARS-CoV-2 immunity clinical trial (Live BASIC trial): a triple-blind randomized controlled trial.

ABSTRACT:

Purpose

With waning immunity and vaccine hesitancy, the COVID-19 pandemic continues to pose risks. 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's efficacy in enhancing anti-SARS-CoV-2 immunity in unvaccinated, previously infected adults.

Methods

We conducted a pilot, parallel-group, triple-blind randomized controlled trial in 2021-2022 involving 52 generally healthy adults ages 18-60, unvaccinated against COVID-19, with SARS-CoV-2 infection ≥ 4 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. Secon

SUBMITTER: Horton DB 

PROVIDER: S-EPMC12864199 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature