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0 0.5 1 1.5 2+ Time to clinical improve.. 11% Improvement Relative Risk Hospitalization time 11% Clinical improvement 83% Clinical improvement (b) 4% Shah et al. Probiotics for COVID-19 RCT LATE TREATMENT Is late treatment with probiotics+multi-enzyme formulation beneficial for COVID-19? RCT 60 patients in India Improved recovery with probiotics+multi-enzyme formulation (p=0.0048) Shah et al., Advances in Clinical Toxicology, doi:10.23880/act-16000204 Favors probiotics Favors control
Potential of the Combination of a Systemic Enzyme Complex and Probiotics administration to Combat COVID-19: A Randomized Open Label Prospective Analysis
Shah et al., Advances in Clinical Toxicology, doi:10.23880/act-16000204
Shah et al., Potential of the Combination of a Systemic Enzyme Complex and Probiotics administration to Combat COVID-19: A.., Advances in Clinical Toxicology, doi:10.23880/act-16000204
Feb 2021   Source   PDF  
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Small RCT 60 patients in India, 30 treated with ImmunoSEB and ProbioSEB CSC3, showing faster recovery with treatment. CTRI/2020/09/027685, CTRI/2020/08/027168.
The immune effects of probiotics are strain-specific.
time to clinical improvement, 10.8% lower, relative time 0.89, p = 0.19, treatment 30, control 30.
hospitalization time, 10.6% lower, relative time 0.89, p = 0.18, treatment 30, control 30.
risk of no clinical improvement, 83.3% lower, RR 0.17, p = 0.005, treatment 2 of 30 (6.7%), control 12 of 30 (40.0%), NNT 3.0, day 10 mid-recovery.
risk of no clinical improvement, 3.7% lower, RR 0.96, p = 1.00, treatment 26 of 30 (86.7%), control 27 of 30 (90.0%), NNT 30, day 7.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Shah et al., 2 Feb 2021, Randomized Controlled Trial, India, peer-reviewed, 3 authors, this trial uses multiple treatments in the treatment arm (combined with multi-enzyme formulation) - results of individual treatments may vary.
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This PaperProbioticsAll
Potential of the Combination of a Systemic Enzyme Complex and Probiotics administration to Combat COVID-19: A Randomized Open Label Prospective Analysis
Clin Adv, Toxicol, Neha Shah, Rohit Parate, Abhay Vispute
Advances in Clinical Toxicology, doi:10.23880/act-16000205
Background: Enzymes have been used for therapeutic applications for decades owing to their anti-inflammatory and immunomodulatory effects. Probiotics are well known to reduce the incidence and severity of several health-related conditions. To our knowledge, no clinical trial has evaluated the effects of a combination of systemic enzyme and probiotic supplementation in Covid-19 patients infected with the SARSCoV-2 virus. Objective: We investigated the safety and efficacy of the health supplements ImmunoSEB (systemic enzyme complex) and ProbioSEB CSC3 (probiotic complex) as supplemental therapy in confirmed mild to moderate COVID-19 patients. Methods: A randomized, open label, 2-arm, prospective study in patients with an RT-PCR confirmed diagnosis of COVID-19 with a mild to moderate condition was conducted. The control arm (n=30) received standard of care (SOC) treatment and the test arm (n=30) received the oral supplements ImmunoSEB (500 mg/cap.) + ProbioSEB CSC3 (5 billion CFUs /cap.) for 14 days in addition to SOC. The efficacy and safety of the experimental regimen was compared with the control arm at various timepoints from days 1 to 21. Results: A significantly higher proportion of patients in the test arm showed clinical improvement on day 10 vs the controls (93.33% vs 60%; p<0.05). No adverse events were reported in the test arm at any time during the study suggesting the safety of supplementation with ImmunoSEB + ProbioSEB CSC3. Patients in the test arm also had a shorter duration of hospitalization, quicker recovery and faster reduction in CRP levels as compared to the control arm. Conclusions: The present study concludes that supplemental therapy with ImmunoSEB + ProbioSEB CSC3 accelerates clinical improvement in mild to moderate COVID-19 patients. While there is no vaccine or specific drug to completely cure SARS CoV-2 infection, the proposed supplemental therapy could be a potential tool to aid in the recovery of COVID-19 of patients.
Author's contribution Dr. Rohit Parate and Dr. Abhay Vispute acted as principal investigators of this study and Dr Neha Shah was involved in study design, planning, protocol writing, data analysis and manuscript preparation.
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Late treatment
is less effective
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