1. Introduction
COVID infecTion, sepsis, diabetes mellitus, coronavirus disease 2019
DIABETES MELLITUS, SEPSIS, CORONAVIRUS DISEASE 2019
These authors contributed equally to this work.Gut microbiota is believed to be a major determinant of health outcomes. We hypothesised that a novel oral microbiome formula (SIM01) can reduce the risk of adverse health outcomes in at-risk subjects during the coronavirus disease 2019 (COVID-19) pandemic. In this single-centre, double-blind, randomised, placebo-controlled trial, we recruited subjects aged ≥65 years or with type two diabetes mellitus. Eligible subjects were randomised in a 1:1 ratio to receive three months of SIM01 or placebo (vitamin C) within one week of the first COVID-19 vaccine dose. Both the researchers and participants were blinded to the groups allocated. The rate of adverse health outcomes was significantly lower in the SIM01 group than the placebo at one month (6 [2.9%] vs. 25 [12.6], Worldwide, the coronavirus disease 2019 (COVID-19) pandemic has posed a substantial challenge in terms of its induced morbidity and mortality to the general population [Accumulating evidence suggests that gut microbiota plays an important role in human health, including digestive functions and the risk of sepsis [To date, large-scale, randomised trials are lacking to evaluate the clinical benefits of probiotics among at-risk individuals. The Immune Microbiome Product Against COVID infecTion (IMPACT) study aimed to assess the efficacy of a novel microbiome immunity formula (SIM01) in reducing adverse health outcomes in the elderly and patients with type two diabetes mellitus during the COVID-19 pandemic. We also assessed whether the use of SIM01 could improve quality of life and gut dysbiosis.