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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Recovery, fatigue 57% Improvement Relative Risk Recovery, memory loss 50% Recovery, concentration 62% Recovery, insomnia 52% Recovery, gastrointestinal.. 50% Recovery, general unwel.. 59% Probiotics  Lau et al.  LATE TREATMENT  DB RCT  LONG COVID Does probiotics reduce the risk of Long COVID (PASC)? Double-blind RCT 463 patients in China (June 2021 - August 2022) Improved recovery with probiotics (p=0.000045) c19early.org Lau et al., The Lancet Infectious Dise.., Dec 2023 Favors probiotics Favors control

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

Lau et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(23)00685-0, NCT04950803
Dec 2023  
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Probiotics for COVID-19
18th treatment shown to reduce risk in March 2021
 
*, now known with p = 0.0000013 from 26 studies.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
3,800+ studies for 60+ treatments. c19early.org
RCT 463 patients with post-acute COVID-19 syndrome (PACS) showing that treatment with a synbiotic preparation (SIM01) containing probiotics and prebiotics was associated with alleviation of multiple PACS symptoms including fatigue, memory loss, difficulty concentrating, gastrointestinal upset, and general unwellness compared to placebo.
The immune effects of probiotics are strain-specific.
risk of no recovery, 57.2% lower, OR 0.43, p < 0.001, treatment 232, control 231, adjusted per study, inverted to make OR<1 favor treatment, multivariable, fatigue, RR approximated with OR.
risk of no recovery, 49.6% lower, OR 0.50, p = 0.002, treatment 232, control 231, adjusted per study, inverted to make OR<1 favor treatment, multivariable, memory loss, RR approximated with OR.
risk of no recovery, 62.2% lower, OR 0.38, p < 0.001, treatment 232, control 231, adjusted per study, inverted to make OR<1 favor treatment, multivariable, concentration, RR approximated with OR.
risk of no recovery, 52.3% lower, OR 0.48, p = 0.002, treatment 232, control 231, adjusted per study, inverted to make OR<1 favor treatment, multivariable, insomnia, RR approximated with OR.
risk of no recovery, 49.9% lower, OR 0.50, p = 0.001, treatment 232, control 231, adjusted per study, inverted to make OR<1 favor treatment, multivariable, gastrointestinal upset, RR approximated with OR.
risk of no recovery, 59.4% lower, OR 0.41, p < 0.001, treatment 232, control 231, adjusted per study, inverted to make OR<1 favor treatment, multivariable, general unwellness, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Lau et al., 7 Dec 2023, Double Blind Randomized Controlled Trial, placebo-controlled, China, peer-reviewed, 16 authors, study period 25 June, 2021 - 12 August, 2022, trial NCT04950803 (history). Contact: siewchienng@cuhk.edu.hk.
This PaperProbioticsAll
A synbiotic preparation (SIM01) for post-acute COVID-19 syndrome in Hong Kong (RECOVERY): a randomised, double-blind, placebo-controlled trial
MSc Raphaela I Lau, PhD, I S F Qi Su, Ivan S F Lau, Jessica Y L Ching, Martin C S Wong, Louis H S Lau, Hein M Tun, Chris K P Mok, Steven W H Chau, Yee Kit Tse, Chun Pan Cheung, Giann Moses K T Li, Giann T Y Yeung, Pui Kuan Cheong, Prof F K L Francis K L Chan, Siew C Ng
The Lancet Infectious Diseases, doi:10.1016/s1473-3099(23)00685-0
Background Post-acute COVID-19 syndrome (PACS) affects over 65 million individuals worldwide but treatment options are scarce. We aimed to assess a synbiotic preparation (SIM01) for the alleviation of PACS symptoms. Methods In this randomised, double-blind, placebo-controlled trial at a tertiary referral centre in Hong Kong, patients with PACS according to the US Centers for Disease Control and Prevention criteria were randomly assigned (1:1) by random permuted blocks to receive SIM01 (10 billion colony-forming units in sachets twice daily) or placebo orally for 6 months. Inclusion criterion was the presence of at least one of 14 PACS symptoms for 4 weeks or more after confirmed SARS-CoV-2 infection, including fatigue, memory loss, difficulty in concentration, insomnia, mood disturbance, hair loss, shortness of breath, coughing, inability to exercise, chest pain, muscle pain, joint pain, gastrointestinal upset, or general unwellness. Individuals were excluded if they were immunocompromised, were pregnant or breastfeeding, were unable to receive oral fluids, or if they had received gastrointestinal surgery in the 30 days before randomisation. Participants, care providers, and investigators were masked to group assignment. The primary outcome was alleviation of PACS symptoms by 6 months, assessed by an interviewer-administered 14-item questionnaire in the intention-to-treat population. Forward stepwise multivariable logistical regression was performed to identify predictors of symptom alleviation. The trial is registered with ClinicalTrials.gov, NCT04950803. Findings Between June 25, 2021, and Aug 12, 2022, 463 patients were randomly assigned to receive SIM01 (n=232) or placebo (n=231). At 6 months, significantly higher proportions of the SIM01 group had alleviation of fatigue (OR 2•273, 95% CI 1•520-3•397, p=0•0001), memory loss (1•967, 1•271-3•044, p=0•0024), difficulty in concentration (2•644, 1•687-4•143, p<0•0001), gastrointestinal upset (1•995, 1•304-3•051, p=0•0014), and general unwellness (2•360, 1•428-3•900, p=0•0008) compared with the placebo group. Adverse event rates were similar between groups during treatment (SIM01 22 [10%] of 232 vs placebo 25 [11%] of 231; p=0•63). Treatment with SIM01, infection with omicron variants, vaccination before COVID-19, and mild acute COVID-19, were predictors of symptom alleviation (p<0•0036). Interpretation Treatment with SIM01 alleviates multiple symptoms of PACS. Our findings have implications on the management of PACS through gut microbiome modulation. Further studies are warranted to explore the beneficial effects of SIM01 in other chronic or post-infection conditions.
Contributors RIL and QS conceived the study, accessed and verified all the data, and prepared the manuscript. ISFL, MCSW, LHSL, and SWHC contributed to participant recruitment and clinical assessment. JYLC contributed to clinical data management and study monitoring. HMT and CKPM contributed to cytokines profiling. YKT provided important comments on statistical analysis. CPC contributed to sample collection and biobank management. MKTL contributed to sample processing and metagenomic sequencing. GTYY and PKC provided important assistance during the clinical trial. FKLC and SCN designed the study and contributed to data interpretation and manuscript writing. All authors read, revised, and had final responsibility for the decision to submit the manuscript for publication and had full access to all the data in the study. Declaration of interests All authors have completed the Unified Competing Interest form (available on request to the corresponding author). MCSW is an advisory committee member of Pfizer, an external expert of GlaxoSmithKline, a member of the advisory board of AstraZeneca, and has been paid consultancy fees for providing advice on research. LHSL is supported by grants from the Health and Medical Research Fund, General Research Fund, and Direct Grant for Research; received honoraria as a speaker for Olympus, Boston Scientific, and GenieBiome; travel grants from Olympus, Pfizer, and AbbVie; and received research product support from GenieBiome for his other..
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Late treatment
is less effective
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