Zobrazeno 1 - 10 of 74 pro vyhledávání: '"Barbara H, McGovern"'
1
Akademický článek
Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI
Autor: Colleen S. Kraft, Matthew Sims, Michael Silverman, Thomas J. Louie, Paul Feuerstadt, Edward S. Huang, Sahil Khanna, Charles S. Berenson, Elaine E. L. Wang, Stuart H. Cohen, Louis Korman, Christine Lee, Colleen R. Kelly, Alberto Odio, Paul P. Cook, Bret Lashner, Mayur Ramesh, Princy Kumar, Ananya De, Asli Memisoglu, David A. Lombardi, Brooke R. Hasson, Barbara H. McGovern, Lisa von Moltke, Darrell S. Pardi, on behalf of the ECOSPOR III and ECOSPOR IV investigators
Publikováno v: Infectious Diseases and Therapy, Vol 13, Iss 10, Pp 2105-2121 (2024)
Abstract Introduction Recurrent Clostridioides difficile infection (rCDI) often occurs after standard-of-care antibiotics. VOWST oral spores (VOS, previously SER-109), an FDA-approved orally administered microbiome therapeutic, is indicated to preven
Externí odkaz: https://doaj.org/article/ba87c7a699914c4c8d06cf93ba025fb8
Zobrazit plný text záznamu
2
Akademický článek
End-to-end donor screening and manufacturing controls: complementary quality-based strategies to minimize patient risk for donor-derived microbiome therapeutics
Autor: Jason Goldsmith, Sarah Tomkovich, John G. Auniņš, Barbara H. McGovern, Jennifer C. Mahoney, Brooke R. Hasson, Christopher W J McChalicher, David S. Ege
Publikováno v: Gut Microbes, Vol 16, Iss 1 (2024)
Advances in microbiome therapeutics have been motivated by a deeper understanding of the role that the gastrointestinal microbiome plays in human health and disease. The FDA approval of two stool-derived live biotherapeutic products (LBPs), REBYOTA®
Externí odkaz: https://doaj.org/article/d50c2aaf0d6047ffbd335412cd5b848c
Zobrazit plný text záznamu
6
Manufacturing Process of SER-109, a Purified Investigational Microbiome Therapeutic, Reduces Risk of Coronavirus Transmission From Donor Stool
Autor: Christopher McChalicher, Ahmad Abdulaziz, S Steve Zhou, Mary-Jane Lombardo, Brooke Hasson, John G Auniņš, Barbara H McGovern, David S Ege
Publikováno v: Open Forum Infectious Diseases. 9
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may present risk to patients treated with donor-derived microbiome therapies when appropriate manufacturing controls and inactivation processes are lacking. We report that the manufacturing
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::53b43b351392961a68ae5aa791af921d
https://doi.org/10.1093/ofid/ofac448
Zobrazit plný text záznamu
8
SER-109, an Investigational Microbiome Drug to Reduce Recurrence After Clostridioides difficile Infection: Lessons Learned From a Phase 2 Trial
Autor: Christopher W.J. McChalicher, Amelia Tomlinson, Patricia Bernardo, Barbara H. McGovern, Matthew R. Henn, Roger J. Pomerantz, Jonathan Winkler, Madhumitha Nandakumar, Mary Jane Lombardo, Christopher A. Desjardins, Christopher B. Ford, Sunny S. Li, Sahil Khanna, Kevin Litcofsky, Elizabeth L. Hohmann, Darrell S. Pardi, Edward J. O’Brien, Jennifer R. Wortman, John G. Aunins, David N. Cook, Michele Trucksis
Publikováno v: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Background Recurrent Clostridioides difficile infection (rCDI) is associated with loss of microbial diversity and microbe-derived secondary bile acids, which inhibit C. difficile germination and growth. SER-109, an investigational microbiome drug of
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::56077cd4aaef412d7f445e75d24d7d83
https://doi.org/10.1093/cid/ciaa387
Zobrazit plný text záznamu
9
Akademický článek
Patterns of hepatitis C virus RNA levels during acute infection: the InC3 study.
Autor: Behzad Hajarizadeh, Bart Grady, Kimberly Page, Arthur Y Kim, Barbara H McGovern, Andrea L Cox, Thomas M Rice, Rachel Sacks-Davis, Julie Bruneau, Meghan Morris, Janaki Amin, Janke Schinkel, Tanya Applegate, Lisa Maher, Margaret Hellard, Andrew R Lloyd, Maria Prins, Gregory J Dore, Jason Grebely, InC3 Study Group
Publikováno v: PLoS ONE, Vol 10, Iss 4, p e0122232 (2015)
BACKGROUND:Understanding the patterns of HCV RNA levels during acute hepatitis C virus (HCV) infection provides insights into immunopathogenesis and is important for vaccine design. This study evaluated patterns of HCV RNA levels and associated facto
Externí odkaz: https://doaj.org/article/a2fd0c89d44b4dd9b40fadee9f8c969b
Zobrazit plný text záznamu

Vyhledávací nástroje:

Upřesnit hledání

Omezení vyhledávání
Plný text Recenzováno Digitální knihovna AV ČR
Zdroje