A synbiotic preparation (SIM01) for post-acute COVID-19 syndrome in Hong Kong (RECOVERY): a randomised, double-blind, placebo-controlled trial

This study is titled “A synbiotic preparation (SIM01) for post-acute COVID-19 syndrome in Hong Kong (RECOVERY): a randomised double-blind placebo-controlled trial” explored the effectiveness of a synbiotic preparation (SIM01) in alleviating symptoms of Post-acute COVID-19 syndrome (PACS)​​.

PACS, a condition affecting over 65 million individuals globally, presents with a range of debilitating symptoms that persist for weeks to years following SARS-CoV-2 infection. Commonly affecting the respiratory, gastrointestinal, and neuropsychiatric systems, PACS significantly impacts daily life. This study focused on addressing the lack of effective treatments for PACS, particularly exploring the role of gut microbiome modulation​​.

The study involved 463 patients who had at least one of 14 PACS symptoms for over four weeks post COVID-19 infection. They were randomly assigned to either receive SIM01 (containing 10 billion colony-forming units) or a placebo orally for six months. The primary outcome was the alleviation of PACS symptoms, assessed via a 14-item questionnaire​​.

The findings revealed that after six months, the SIM01 group showed significantly higher alleviation in fatigue, memory loss, difficulty in concentration, gastrointestinal upset, and general unwellness compared to the placebo group. Notably, treatment with SIM01, along with factors like infection with omicron variants, prior vaccination, and mild acute COVID-19, were predictors of symptom alleviation​​.

Metagenomic analysis indicated that SIM01 treatment led to increased bacterial diversity and richness, with a significant decrease in antimicrobial resistant genes in the gut microbiome. These microbiome changes correlated with symptom alleviation, suggesting a potential mechanism for the observed benefits​​.

Interestingly, the study did not find a significant difference in quality of life and physical activity between the two groups after six months. It underlines that while SIM01 primarily impacts physical symptoms, these are just one aspect of the broader quality of life domains​​.

The study concludes by noting its strengths, including a diverse patient population and correlation between clinical efficacy and gut microbial changes. However, it also acknowledges limitations, such as the complexity of assessing PACS treatment outcomes and the need for further validation in multi-center, ethnically diverse trials​​.

In summary, this study provides promising evidence for using SIM01 to alleviate various symptoms of PACS, potentially through modulating the gut microbiome. However, further research is needed to confirm these findings and explore additional therapeutic mechanisms for PACS in the post-COVID era.

Read More: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(23)00685-0/fulltext

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