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Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI

2024; Adis, Springer Healthcare; Volume: 13; Issue: 10 Linguagem: Inglês

10.1007/s40121-024-01007-z

2193-8229

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, Aslı Memişoğlu, David A. Lombardi, Brooke R. Hasson, Barbara H. McGovern, Lisa Von Moltke, Darrell S. Pardi, Anmar Hemaidan, Bharat Misra, Richard Nathan, Hien Nguyen, John Pullman, Jeffrey G. Williams, Idalia Acosta, Huy Tran, Kevin M. Smith, Leonard B. Weinstock, Val Hansen, Michael Georgetson, Aasim Sheikh, Julia Garcia‐Diaz, Calin Arimie, Gladys Andrade, Steven O’Marro, Tuba Esfandyari, Timothy E. Ritter, Ian Mcnicol Baird, Ronald Colman, Meenakshi Patel, Lilliam Hernandez, Atoya Adams, Marie Walton, Razvan Arsenescu, Max Shapiro, Marvin Heuer, Tatiana Bogdanovich, Doria Grimard, Theodore S. Steiner, Debra Butt, Peter Daley, Stephanie Gauthier, Chantal Guímont, Leonard B. Weinstock, Michael Kreines, Larry Berman, Michael Bennett, Ronald Fogel, Juan Carlos Moises Gutierrez, P.C. Pedersen, Adam Bressler, Venkatesh Nadar, Eric Newton, Jorge Díaz, Jalal Abbas, Herbert L. DuPont, Aamir Jamal, Neetu Talreja, Sabrina Benjamin, Kamran Ayub, Godson Oguchi, Jose Pinero, Gowrappala Ramesh, Paul S. Sepe, Loren Brook, Frederick Ruthardt, Lindsey Surace, Ayub Hussain, Travis J. Rutland, Michael J. Schmalz, Gourisankar Degala, Raymond E. Phillips, Kent Stock, Jeffrey Bullock, Kenolisa Onwueme, Kenneth M. Johnson, Suzy Kim, Edward Portnoy, Scott Wofford, John Gancayco, Yoav Golan, Charles F. Barish, JeanMarie Houghton, Benton Oubre, Zeid Kayali, Magued Beshay, John Curran, Issa Ephtimios, Michael J. Tan, Angelo Coppola, Syed Naqvi, Richard Caradonna, Subhash Gumber, Sebastian Stanciu, Keith Friedenberg, Satinder Gill, Jaynier Moya, Olayemi Osiyemi, Jerry Stern, Alfred E. Bacon, Matthew Hall, Gail Hecht, Tariq Mehmood, James Haaksma, Lucky Flores, Brian Behm, Jeffrey R. Garber, Tom Welton, James Welker, Alex Sherman, Charles Okolo, Ravish Parekh, R.A. Black, Peter Higgins, Patricia Henry, Alexander Dela Llana, Shalini Katikaneni, Sanjeev Kumar, R. Mason, Jennifer Vincent, Ghassan J. Hadi, М. М. Коган, Ifzal Bangash, Robert D. Orr, Saad F. Jazrawi, Michael Galambos, R. Jaeger, Rizwana Thanawala, Magued Beshay, John Curran, Ernest Hendrix, Matthew E. Parker, Mohammed Mazen Jamal, Ralf E. Gebhard, Sadia Dar, Bruce Branin, Rodolfo Hanabergh, Syed Nasir Husain, Govinda Lohani, Shatishkumar Patel, Mousab Tabbaa, Teresa Alfonso, Anubha Gupta, Antonio Terrelonge, Satish S.C. Rao, D. C. Powell, Robert P. Brennan, Allan Coates, Andrew Donald Gentry, Jason Wilson, Shiwali Rai, Kenneth Boren, Chandar Singaram, Todd B. Ellerin, Myung Chul Choi, David Dulitz, Emil Valle, Atsushi Skuraba, John De Beixedon, Diane Carbonneau, Bruce Musgrave, Zahid N. Zafar, Pradeep Bekal, Eliot Godofsky, H Sarles, Yaneicy Gonzalez‐Rojas, Miguel E. Trevino, Ahmed A. Arif, Chad M. Gonzales, Maria Cubillas, A.A. Kuliev, Vivaik Tyagi, George Dickstein, Rukan Daccak, Roberto Fernandez, Ankur Doshi, Kofi W. Nauako, Sushma V. Gorrela, Babatunde Adeyafa, Harold G. Preiksaitis, James A. Maher, Eugene F. Yen, Najwa El‐Nachef, Larry E. Clark, John J. Hong, Naval Parikh, Juan Sarol, Syed M. Rehman, John Joseph, Markian R. Bochan, Marco Zahedi, P Salvato, Dhaval Patel, F Tiongco, Shari E. Rozen,

Gut microbiota and health

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 prevent rCDI following antibiotics for rCDI.