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All Studies   Meta Analysis       

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, PROTECT-EHC, NCT04399252
Jan 2022  
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Moderate/severe case 33% Improvement Relative Risk Symp. case 38% primary Recovery time 27% Case 43% Probiotics  PROTECT-EHC  Prophylaxis  DB RCT Is prophylaxis with probiotics beneficial for COVID-19? Double-blind RCT 182 patients in the USA (June 2020 - July 2021) Fewer symptomatic cases with probiotics (p=0.02) c19early.org Wischmeyer et al., medRxiv, January 2022 Favorsprobiotics Favorscontrol 0 0.5 1 1.5 2+
Probiotics for COVID-19
18th treatment shown to reduce risk in March 2021, now with p = 0.0000011 from 28 studies.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
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.
Probiotic efficacy depends on the specific strains used. Specific microbes may decrease or increase COVID-19 risk1.
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, study period 24 June, 2020 - 8 July, 2021, trial NCT04399252 (history) (PROTECT-EHC).
This PaperProbioticsAll
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
doi:10.1101/2022.01.04.21268275
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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Tang, Bohannon, Lew, Randomised, double-blind, placebo-controlled trial of Probiotics To Eliminate COVID-19 Transmission in Exposed Household Contacts (PROTECT-EHC): a clinical trial protocol, BMJ Open
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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.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To determine ' 'whether daily probiotic<jats:italic>Lactobacillus rhamnosus</jats:italic>GG (LGG) is ' 'effective in preventing development of symptoms of illness within 28 days of COVID-19 ' 'exposure.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>This ' 'randomized, double-blind, placebo-controlled trial across the United States (PROTECT-EHC) ' 'enrolled in 2020-2021. Participants were followed for 60 ' 'days.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Intervention</jats:title><jats:p>Participants ' 'were randomized to receive daily oral LGG or microcrystalline cellulose placebo for 28 ' 'days.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and ' 'Measures</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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).</jats:p></jats:sec><jats:sec><jats:title>Conclusions and ' 'Relevance</jats:title><jats:p>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<jats:italic>Lactobacillus</jats:italic>probiotics have already been utilized to reduce ' 'non-COVID sepsis and infectious-morbidity. This study was limited by its remote format, which ' 'necessitated a primary endpoint of self-reported symptoms rather than laboratory-confirmed ' 'infection; further laboratory-based studies are needed to further define the efficacy of LGG ' 'in preventing COVID-19 infection, especially in larger populations and including comparison ' 'of pre-exposure vs. post-exposure prophylaxis.</jats:p></jats:sec><jats:sec><jats:title>Trial ' 'registration</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ' 'ext-link-type="uri" ' 'xlink:href="https://clinicaltrials.gov/">ClinicalTrials.gov</jats:ext-link>,<jats:ext-link ' 'xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" ' 'xlink:href="NCT04399252">NCT04399252</jats:ext-link>,<jats:ext-link ' 'xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" ' 'xlink:href="https://clinicaltrials.gov/ct2/show/NCT04399252">https://clinicaltrials.gov/ct2/show/NCT04399252</jats:ext-link></jats:p></jats:sec><jats:sec><jats:title>KEY ' 'POINTS</jats:title><jats:sec><jats:title>Question</jats:title><jats:p>Is daily ' 'probiotic<jats:italic>Lactobacillus rhamnosus</jats:italic>GG (LGG) effective in preventing ' 'development of symptoms of illness compatible with COVID-19 within 28 days of COVID-19 ' 'exposure compared to ' 'placebo?</jats:p></jats:sec><jats:sec><jats:title>Findings</jats:title><jats:p>In this ' 'randomized clinical trial that included 182 participants, the proportion who developed ' 'symptoms was 26.4% with LGG versus 42.9% with placebo, a significant ' 'difference.</jats:p></jats:sec><jats:sec><jats:title>Meaning</jats:title><jats:p>LGG ' 'probiotic may protect against the development of symptoms when used as post-exposure ' 'prophylaxis within 7 days after COVID-19 exposure.</jats:p></jats:sec></jats:sec>', 'DOI': '10.1101/2022.01.04.21268275', 'type': 'posted-content', 'created': {'date-parts': [[2022, 1, 5]], 'date-time': '2022-01-05T19:30:14Z', 'timestamp': 1641411014000}, 'source': 'Crossref', 'is-referenced-by-count': 17, 'title': 'Daily Lactobacillus Probiotic versus Placebo in COVID-19-Exposed Household Contacts ' '(PROTECT-EHC): A Randomized Clinical Trial', 'prefix': '10.1101', 'author': [ {'given': 'Paul E.', 'family': 'Wischmeyer', 'sequence': 'first', 'affiliation': []}, {'given': 'Helen', 'family': 'Tang', 'sequence': 'additional', 'affiliation': []}, {'given': 'Yi', 'family': 'Ren', 'sequence': 'additional', 'affiliation': []}, {'given': 'Lauren', 'family': 'Bohannon', 'sequence': 'additional', 'affiliation': []}, {'given': 'Zeni E.', 'family': 'Ramirez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Tessa M.', 'family': 'Andermann', 'sequence': 'additional', 'affiliation': []}, {'given': 'Julia A.', 'family': 'Messina', 'sequence': 'additional', 'affiliation': []}, {'given': 'Julia A.', 'family': 'Sung', 'sequence': 'additional', 'affiliation': []}, {'given': 'David', 'family': 'Jensen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sin-Ho', 'family': 'Jung', 'sequence': 'additional', 'affiliation': []}, {'given': 'Alexandra', 'family': 'Artica', 'sequence': 'additional', 'affiliation': []}, {'given': 'Anne', 'family': 'Britt', 'sequence': 'additional', 'affiliation': []}, {'given': 'Amy', 'family': 'Bush', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ernaya', 'family': 'Johnson', 'sequence': 'additional', 'affiliation': []}, {'given': 'Meagan V.', 'family': 'Lew', 'sequence': 'additional', 'affiliation': []}, {'given': 'Hilary M.', 'family': 'Miller', 'sequence': 'additional', 'affiliation': []}, {'given': 'Claudia E.', 'family': 'Pamanes', 'sequence': 'additional', 'affiliation': []}, {'given': 'Alessandro', 'family': 'Racioppi', 'sequence': 'additional', 'affiliation': []}, {'given': 'Aaron T.', 'family': 'Zhao', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-9544-2551', 'authenticated-orcid': False, 'given': 'Neeraj K.', 'family': 'Surana', 'sequence': 'additional', 'affiliation': []}, {'given': 'Anthony D.', 'family': 'Sung', 'sequence': 'additional', 'affiliation': []}], 'member': '246', 'reference': [ { 'key': '2022010703551062000_2022.01.04.21268275v1.1', 'unstructured': 'WHO COVID-19 Dashboard. 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' 'Nutrients. 2017;9(11).', 'DOI': '10.3390/nu9111175'}], 'container-title': [], 'original-title': [], 'link': [ { 'URL': 'https://syndication.highwire.org/content/doi/10.1101/2022.01.04.21268275', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2023, 11, 15]], 'date-time': '2023-11-15T11:03:44Z', 'timestamp': 1700046224000}, 'score': 1, 'resource': {'primary': {'URL': 'http://medrxiv.org/lookup/doi/10.1101/2022.01.04.21268275'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 1, 5]]}, 'references-count': 30, 'URL': 'http://dx.doi.org/10.1101/2022.01.04.21268275', 'relation': {}, 'published': {'date-parts': [[2022, 1, 5]]}, 'subtype': 'preprint'}
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