دورية أكاديمية
Efficacy of probiotic treatment as post-exposure prophylaxis for COVID-19: A double-blind, Placebo-Controlled Randomized trial.
| العنوان: | Efficacy of probiotic treatment as post-exposure prophylaxis for COVID-19: A double-blind, Placebo-Controlled Randomized trial. |
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| المؤلفون: | Wischmeyer PE; Duke University School of Medicine, Department of Anesthesiology, Durham, NC, USA. Electronic address: Paul.Wischmeyer@Duke.edu., Tang H; Duke University School of Medicine, Durham, NC, USA., Ren Y; Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, NC, USA., Bohannon L; Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, NC, USA., Jiang D; Division of Infectious Diseases, Department of Pediatrics, Duke University, Durham, NC, USA; Program in Computational Biology and Bioinformatics, Duke University, Durham, NC, USA., Bergens M; Duke University School of Medicine, Durham, NC, USA., Ramirez ZE; Division of Infectious Diseases, Department of Pediatrics, Duke University, Durham, NC, USA; Department of Molecular Genetics and Microbiology, Duke University, Durham, NC, USA., Andermann TM; Division of Infectious Diseases, Department of Medicine, University of North Carolina, Chapel Hill, NC, USA., Messina JA; Division of Infectious Diseases, Department of Medicine, Duke University, Durham, NC, USA., Sung JA; Division of Infectious Diseases, Department of Medicine, University of North Carolina, Chapel Hill, NC, USA., Jensen D; Duke University School of Medicine, Durham, NC, USA., Jung SH; Duke University School of Medicine, Durham, NC, USA., Artica A; Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, NC, USA., Britt A; Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, NC, USA., Bush A; Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, NC, USA., Johnson E; Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, NC, USA., Lew MV; Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, NC, USA., Winthrop H; Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, NC, USA., Pamanes C; Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, NC, USA., Racioppi A; Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, NC, USA., Zhao AT; Duke University Trinity College of Arts & Sciences, Durham, NC, USA., Wan Z; Duke University School of Medicine, Durham, NC, USA., Surana NK; Division of Infectious Diseases, Department of Pediatrics, Duke University, Durham, NC, USA; Department of Molecular Genetics and Microbiology, Duke University, Durham, NC, USA., Sung AD; Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, NC, USA. |
| المصدر: | Clinical nutrition (Edinburgh, Scotland) [Clin Nutr] 2024 Jan; Vol. 43 (1), pp. 259-267. Date of Electronic Publication: 2023 Dec 11. |
| نوع المنشور: | Randomized Controlled Trial; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: England NLM ID: 8309603 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-1983 (Electronic) Linking ISSN: 02615614 NLM ISO Abbreviation: Clin Nutr Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2004->: Kidlington, Oxford, U.K. : Elsevier Original Publication: Edinburgh ; New York : Churchill Livingstone, c1982- |
| مواضيع طبية MeSH: | COVID-19*/epidemiology , COVID-19*/prevention & control , Probiotics*/therapeutic use, Humans ; Post-Exposure Prophylaxis ; Pandemics/prevention & control ; COVID-19 Testing ; Double-Blind Method |
| مستخلص: | Background & Aims: The COVID-19 pandemic continues to pose unprecedented challenges to worldwide health. While vaccines are effective, additional strategies to mitigate the spread/severity of COVID-19 continue to be needed. Emerging evidence suggests susceptibility to respiratory tract infections in healthy subjects can be reduced by probiotic interventions; thus, probiotics may be a low-risk, low-cost, and easily implementable modality to reduce risk of COVID-19. Methods: In this initial study, we conducted a randomized, double-blind, placebo-controlled trial across the United States testing probiotic Lacticaseibacillus rhamnosus GG (LGG) as postexposure prophylaxis for COVID-19 in 182 participants who had household exposure to someone with confirmed COVID-19 diagnosed within ≤7 days. Participants were randomized to receive oral LGG or placebo for 28 days. The primary outcome was development of illness symptoms within 28 days of COVID-19 exposure. Stool was collected to evaluate microbiome changes. Results: Intention-to-treat analysis showed LGG treatment led to a lower likelihood of developing illness symptoms versus 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). Conclusions: This data suggests LGG is associated with prolonged time to COVID-19 infection, reduced incidence of illness symptoms, and gut microbiome changes when used as prophylaxis ≤7 days post-COVID-19 exposure, but not overall incidence. This initial work may inform future COVID-19 prevention studies worldwide, particularly in developing nations where Lacticaseibacillus probiotics have previously been utilized to reduce other non-COVID infectious-morbidity. Trial Registration: ClinicalTrials.gov, NCT04399252, Date: 22/05/2020. https://clinicaltrials.gov/ct2/show/NCT04399252. Competing Interests: Conflict of interest P.E.W. has received unrestricted gift funding from DSM/iHealth and has an investigator-initiated research grant from Abbott Inc. related to work focused on microbiome and probiotic research. P.E.W. has presented CME lectures for DSM on probiotic research. All other authors declare no competing interests. A.D.S has grants from Merck Sharpe & Dohme, consulting for Targazyme, and receipt of supplies from Clasado. (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.) |
| فهرسة مساهمة: | Keywords: COVID-19; Clinical trial; Lacticaseibacillus; Microbiome; Probiotics; Prophylaxis |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04399252 |
| تواريخ الأحداث: | Date Created: 20231216 Date Completed: 20231226 Latest Revision: 20240415 |
| رمز التحديث: | 20240416 |
| DOI: | 10.1016/j.clnu.2023.11.043 |
| PMID: | 38103462 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1532-1983 |
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| DOI: | 10.1016/j.clnu.2023.11.043 |