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0 0.5 1 1.5 2+ Moderate/severe case 33% Improvement Relative Risk Symptomatic case 38% primary Recovery time 27% Case 43% Wischmeyer et al. NCT04399252 PROTECT-EHC Probiotics RCT Prophylaxis Is prophylaxis with probiotics beneficial for COVID-19? Double-blind RCT 182 patients in the USA Fewer symptomatic cases with probiotics (p=0.02) Wischmeyer et al., medRxiv, doi:10.1101/2022.01.04.21268275 Favors probiotics Favors control
Daily Lactobacillus Probiotic versus Placebo in COVID-19-Exposed Household Contacts (PROTECT-EHC): A Randomized Clinical Trial
Wischmeyer et al., medRxiv, doi:10.1101/2022.01.04.21268275 (Preprint), PROTECT-EHC, NCT04399252 (history)
Wischmeyer et al., Daily Lactobacillus Probiotic versus Placebo in COVID-19-Exposed Household Contacts (PROTECT-EHC): A.., medRxiv, doi:10.1101/2022.01.04.21268275 (Preprint), PROTECT-EHC, NCT04399252
Jan 2022   Source   PDF  
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RCT 182 COVID-19 exposed patients, 91 treated with daily probiotic Lactobacillus rhamnosus GG starting a median of 3 days from exposure, showing lower symptomatic COVID-19 with treatment. There were no hospitalizations or deaths.
The immune effects of probiotics are strain-specific.
risk of moderate/severe case, 33.3% lower, RR 0.67, p = 0.15, treatment 16 of 91 (17.6%), control 24 of 91 (26.4%), NNT 11.
risk of symptomatic case, 38.5% lower, RR 0.62, p = 0.02, treatment 24 of 91 (26.4%), control 39 of 91 (42.9%), NNT 6.1, primary outcome.
recovery time, 27.3% lower, relative time 0.73, p = 0.37, treatment 91, control 91.
risk of case, 42.9% lower, RR 0.57, p = 0.17, treatment 8 of 91 (8.8%), control 14 of 91 (15.4%), NNT 15.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Wischmeyer et al., 5 Jan 2022, Double Blind Randomized Controlled Trial, USA, preprint, 21 authors, trial NCT04399252 (history) (PROTECT-EHC).
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Daily Lactobacillus Probiotic versus Placebo in COVID-19-Exposed Household Contacts (PROTECT-EHC): A Randomized Clinical Trial
MD Paul E Wischmeyer, Helen Tang, MS Yi Ren, BS Lauren Bohannon, BS Zeni E Ramirez, MD Tessa M Andermann, MD Julia A Messina, MD Julia A Sung, PhD David Jensen, PhD Sin-Ho Jung, Alexandra Artica, MHA Anne Britt, Amy Bush, MS Ernaya Johnson, BS Meagan V Lew, MS Hilary M Miller, MPH Claudia E Pamanes, MS Alessandro Racioppi, Aaron T Zhao, MD Neeraj K Surana, MD Anthony D Sung
Importance: The COVID-19 pandemic continues to pose unprecedented challenges to worldwide health. While vaccines are effective, supplemental strategies to mitigate the spread and severity of COVID-19 are urgently needed. Emerging evidence suggests susceptibility to infections, including respiratory tract infections, may be reduced by probiotic interventions; therefore, probiotics may be a low-risk, widely implementable modality to mitigate risk of COVID-19 disease, particularly in areas with low vaccine availability and/or uptake. Objective: To determine whether daily probiotic Lactobacillus rhamnosus GG (LGG) is effective in preventing development of symptoms of illness within 28 days of COVID-19 exposure. Design: This randomized, double-blind, placebo-controlled trial across the United States (PROTECT-EHC) enrolled in 2020-2021. Participants were followed for 60 days. Setting: Describe the study setting to assist readers to determine the applicability of the report to other circumstances, for example, multicenter, population-based, primary care or referral center(s), etc. Participants: Participants included individuals > 1 year of age with a household contact with a recent (≤ 7 days) diagnosis of COVID-19. 182 participants were enrolled and randomized during the study period. Intervention: Participants were randomized to receive daily oral LGG or microcrystalline cellulose placebo for 28 days. Main Outcomes and Measures: The primary outcome was development of symptoms within 28 days of exposure to a COVID-19-infected household contact. Stool was collected to evaluate for changes in microbiome structure. Results: 182 participants were enrolled and randomized during the study period. Intention-to-treat analysis showed that participants randomized to LGG were less likely to develop symptoms versus those randomized to placebo (26.4% vs. 42.9%, p=0.02). Further, LGG was associated with a statistically significant reduction in COVID-19 diagnosis (log rank p=0.049) via time-to-event analysis. Overall incidence of COVID-19 diagnosis did not significantly differ between LGG and placebo groups (8.8% vs. 15.4%, p=0.17). LGG was well-tolerated with no increased side effects versus placebo. Placebo recipients were more likely to stop the study product, temporarily or permanently, due to symptoms attributed to the study product (5.5% vs. 0%, p = 0.02). Conclusions and Relevance: Our study suggests that LGG is well-tolerated and is associated with prolonged time to development of COVID-19 infection, reduced incidence of symptoms, and changes to gut microbiome structure when used as post-exposure prophylaxis within 7 days after exposure. This preliminary work may inform the approach to prevention of COVID-19, particularly in underdeveloped nations where Lactobacillus probiotics have already been
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Please send us corrections, updates, or comments. Vaccines and treatments are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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