Updates are available Correction dated 2024-08-30
Click to view Correction: https://doi.org/10.1007/s40121-024-01036-8
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Authors
Kraft, Colleen S.
Sims, Matthew
Silverman, Michael
Louie, Thomas J.
Feuerstadt, Paul
Huang, Edward S.
Khanna, Sahil
Berenson, Charles S.
Wang, Elaine E. L.
Cohen, Stuart H.
Korman, Louis
Lee, Christine
Kelly, Colleen R.
Odio, Alberto
Cook, Paul P.
Lashner, Bret
Ramesh, Mayur
Kumar, Princy
De, Ananya
Memisoglu, Asli
Lombardi, David A.
Hasson, Brooke R. http://orcid.org/0009-0000-2991-0567
McGovern, Barbara H.
von Moltke, Lisa
Pardi, Darrell S.
,
Hemaidan, Anmar
Misra, Bharat
Nathan, Richard
Nguyen, Hien
Pullman, John
Williams, Jeffrey
Acosta, Idalia
Tran, Huy
Smith, Kent
Weinstock, Leonard
Hansen, Val
Georgetson, Michael
Sheikh, Aasim
Garcia-Diaz, Julia
Arimie, Calin
Andrade, Gladys
O’Marro, Steven
Esfandyari, Tuba
Ritter, Timothy
Baird, Ian Mcnicol
Colman, Ronald
Patel, Meenakshi
Hernandez, Lilliam
Adams, Atoya
Walton, Marie
Arsenescu, Razvan
Shapiro, Max
Heuer, Marvin
Bogdanovich, Tatiana
Grimard, Doria
Steiner, Theodore
Butt, Debra
Daley, Peter
Gauthier, Stephanie
Guimont, Chantal
Weinstock, Leonard
Kreines, Michael
Berman, Larry
Bennett, Michael
Fogel, Ronald
Gutierrez, Juan Carlos Moises
Pedersen, Peder
Bressler, Adam
Nadar, Venkatesh
Newton, Eric
Diaz, Jorge
Abbas, Jalal
DuPont, Herbert
Jamal, Aamir
Talreja, Neetu
Benjamin, Sabrina
Ayub, Kamran
Oguchi, Godson
Pinero, Jose
Ramesh, Gowrappala
Sepe, Paul
Brook, Loren
Ruthardt, Frederick
Surace, Lindsey
Hussain, Ayub
Rutland, Travis
Schmalz, Michael
Degala, Gourisankar
Phillips, Raymond
Stock, Kent
Bullock, Jeffrey
Onwueme, Kenolisa
Johnson, Kenneth
Kim, Suzy
Portnoy, Edward
Wofford, Scott
Gancayco, John
Golan, Yoav
Barish, Charles
Houghton, JeanMarie
Oubre, Benton
Kayali, Zeid
Beshay, Magued
Curran, John
Ephtimios, Issa
Tan, Michael
Coppola, Angelo
Naqvi, Syed
Caradonna, Richard
Gumber, Subhash
Stanciu, Sebastian
Friedenberg, Keith
Gill, Satinder
Moya, Jaynier
Osiyemi, Olayemi
Stern, Jerry
Bacon, Alfred
Hall, Matthew
Hecht, Gail
Mehmood, Tariq
Haaksma, James
Flores, Lucky
Behm, Brian
Garber, Jeffrey
Welton, Thomas
Welker, James
Sherman, Alex
Okolo, Charles
Parekh, Ravish
Black, Richard
Higgins, Peter
Henry, Patricia
Llana, Alexander Dela
Katikaneni, Shalini
Kumar, Sanjeev
Mason, Raymond
Vincent, Jennifer
Hadi, Ghassan
Kogan, Mark
Bangash, Ifzal
Orr, Robert
Jazrawi, Saad
Galambos, Michael
Jaeger, Robert
Thanawala, Rizwana
Beshay, Magued
Curran, John
Hendrix, Ernest
Parker, Matthew
Jamal, Mohammed Mazen
Gebhard, Ralf
Dar, Sadia
Branin, Bruce
Hanabergh, Rodolfo
Husain, Syed Nasir
Lohani, Govinda
Patel, Shatishkumar
Tabbaa, Mousab
Alfonso, Teresa
Gupta, Anubha
Terrelonge, Antonio
Rao, Satish
Powell, Debra
Brennan, Robert
Coates, Allan G.
Gentry, Andrew
Wilson, Jason
Rai, Shiwali
Boren, Kenneth
Singaram, Chandar
Ellerin, Todd B.
Choi, Myung
Dulitz, David
Valle, Emil
Skuraba, Atsushi
De Beixedon, John
Carbonneau, Diane
Musgrave, Bruce
Zafar, Zahid N.
Bekal, Pradeep Kumar
Godofsky, Eliot
Sarles, Harry
Gonzalez-Rojas, Yaneicy
Trevino, Miguel E.
Arif, Ahmed A.
Gonzales, Chad M.
Cubillas, Maria
Kuliev, Agadasah
Tyagi, Vivaik
Dickstein, George
Daccak, Rukan
Fernandez, Roberto
Doshi, Ankur A.
Nauako, Kofi W.
Gorrela, Sushma V.
Adeyafa, Babatunde
Preiksaitis, Harold G.
Maher, James A.
Yen, Eugene F.
El-Nachef, Najwa
Clark, Larry E.
Hong, John
Parikh, Naval
Sarol, Juan
Rehman, Syed M.
Joseph, John M.
Bochan, Markian R.
Zahedi, Marco
Salvato, Patricial
Patel, Dhaval
Tiongco, Feliz P.
Rozen, Shari E.
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Clinical Trials BETA
Clinical trials referenced in this document:
nct03183128 at ClinicalTrials.govnct03183141 at ClinicalTrials.govDocuments that mention this clinical trial
Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI
https://doi.org/10.1007/s40121-024-01007-z
Documents that mention this clinical trial
Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI
https://doi.org/10.1007/s40121-024-01007-z
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Funding
Funding for this research was provided by:
Seres Therapeutics
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More Information
Article History
Received: 27 February 2024
Accepted: 29 April 2024
First Online: 28 June 2024
Change Date: 30 August 2024
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s40121-024-01036-8
Declarations
:
: Colleen Kraft reported serving on the scientific advisory board for Seres Therapeutics and serves as a consultant for Rebiotix/Ferring. Matthew Sims reported serving as an advisory board member for Prenosis, consultant for Applied BioCode, CorMedix, and Venatorx, and also reported serving as a principal investigator or co-investigator for the following companies: AstraZeneca, ContraFect, Crestone, Curetis GmBH, Pfizer, DiaSorin Molecular LLC, Epigenomics Inc, EUROIMMUN US, Finch Therapeutics, Adaptive Phage Genetics Biotest AG—PI, Dompe, Pfizer, Genentech USA Inc, Janssen Research and Development, LLC, Kinevant Sciences GmBH, Leonard-Meron Biosciences, Merck, Prenosis, QIAGEN Sciences LC, Regeneron Pharmaceuticals, Roche, Seres Therapeutics, Shire, and Summit Therapeutics. Christine Lee reported receiving grants from Rebiotix/Ferring, Seres, Merck and Summit Therapeutics to conduct clinical trials. Paul Feuerstadt reported serving as a consultant for Merck and Co. and also reported serving on the speakers bureau and on consulting/advisory boards for the following companies: Seres Therapeutics, Ferring/Rebiotix, and Takeda Pharmaceuticals. Sahil Khanna receives research support from Rebioitx/Ferring, Vedanta, Finch, Seres and Pfizer and serves as a consultant for ProbioTech, Takeda, Niche and Immuron. Colleen Kelly reported serving as a site investigator for Seres Therapeutics and Finch Therapeutics; serving as a clinical advisory board member (unpaid) for Openbiome; as well as serving as a consultant for Sebela Pharmaceuticals. Princy Kumar reported serving as an investigator/receiving research funds from ViiV, Gilead, Merck, and Theratechnologies; serving as a consultant for Viiv, Gilead, and Merck; serving on the Advisory Committee/Board for GSK, Gilead, and Merck; and is a shareholder of Pfizer, GSK, Gilead, and Merck. Brooke Hasson and Lisa von Moltke are employees and shareholders of Seres Therapeutics. Lisa von Moltke is an employee and shareholder of Seres Therapeutics and is also a shareholder and serves on the Board of Directors for Cara Therapeutics. Barbara McGovern, Ananya De, Elaine Wang, Asli Memisoglu, and David Lombardi are all former employees of Seres Therapeutics. Darrell Pardi reported receiving research grants from the following companies: Seres Therapeutics, Vedanta, Finch, Takeda, Applied Molecular Transport and also reported serving as a consultant for: Seres Therapeutics, Vedanta, Immunic Therapeutics, Abbvie, Otsuka, Ferring, Rise Therapeutics, Boehringer Ingelheim, and Summit. Paul Cook is a principal investigator for Gilead, Pfizer, Abbvie and the National Institutes of Health. Louis Korman, Charles Berenson, Mayur Ramesh, Bret Lashner, Alberto Odio, Edward Huang, and Stuart Cohen were study investigators. No other disclosures were reported.
: Both trials were performed in accordance with Good Clinical Practice and with the Helsinki Declaration of 1964 and its later amendments. The protocols and amendments were reviewed and approved by local or central investigational review boards. There was no main center for either study, but the central investigational review board was WIRB Copernicus. A table of all investigational review boards is provided in the Supplementary Material. Written informed consent was obtained at screening. All patients were informed that by signing the informed consent document that they agreed to take part in the study and that they read and understood the information presented within, including that the results of the study may be shared with regulatory agencies, at scientific conferences, or through publications.
