Khanna, Sahil http://orcid.org/0000-0002-7619-8338
Assi, Maha
Lee, Christine
Yoho, David
Louie, Thomas
Knapple, Whitfield
Aguilar, Humberto
Garcia-Diaz, Julia
Wang, Gary P.
Berry, Scott M.
Marion, Joe
Su, Xin
Braun, Tricia
Bancke, Lindy
Feuerstadt, Paul
Clinical trials referenced in this document:
Documents that mention this clinical trial
Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection
https://doi.org/10.1007/s40265-022-01797-x
Efficacy and Health-Related Quality of Life Impact of Fecal Microbiota, Live-jslm: A Post Hoc Analysis of PUNCH CD3 Patients at First Recurrence of Clostridioides difficile Infection
https://doi.org/10.1007/s40121-023-00907-w
Funding for this research was provided by:
Rebiotix Inc., a Ferring Company
Article History
Accepted: 19 October 2022
First Online: 26 October 2022
Change Date: 7 November 2022
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s40265-022-01805-0
Declarations
:
: Rebiotix Inc., a Ferring Company, provided financial support for this work. The study protocol was developed by Rebiotix Inc., a Ferring Company, in collaboration with the study investigators. Rebiotix Inc. was also involved in data collection, analysis, and interpretation of results. Statistical analyses were performed by statisticians at Rebiotix Inc.
: Sahil Khanna has received grants or contracts from Rebiotix (a Ferring company), Finch Therapeutics, Seres Therapeutics, and Vedanta BioSciences, consulting fees from Niche Pharmaceuticals and Immuron Limited, participated on advisory or data safety monitoring boards for Ferring Pharmaceuticals, and has stock options with Jetson Probiotics. Christine Lee has received grants or contracts from Rebiotix, Inc., Seres Therapeutics, and Summit Therapeutic and participated on advisory or data safety monitoring boards for Ferring Pharmaceuticals and Pfizer. Thomas Louie has received consulting fees from Crestone, MGB BioPharma, Rebiotix, Inc., and Seres Therapeutics and participated on advisory boards for Seres Therapeutics and Vedanta BioSciences. Scott M. Berry has ownership in Berry Consultants who received fees for trial design and analyses; Tricia Braun, Lindy Bancke, and Xin Su are employees of Rebiotix, Inc. or were during conduct of the study. Paul Feuerstadt has received consulting fees from Rebiotix, Inc. and Takeda Pharmaceuticals, honoraria from Ferring Pharmaceuticals, Seres Therapeutics, and Takeda Pharmaceuticals, and participated on advisory or data safety monitoring boards for Ferring Pharmaceuticals, Seres Therapeutics, and Takeda Pharmaceuticals. Humberto Aguilar, Maha Assi, Julia Garcia-Diaz, Whitfield Knapple, Gary P. Wang, and David Yoho have no conflicts of interest to declare.
: All procedures performed in studies involving participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
: Informed consent was obtained from all individual participants included in the study.
: Not applicable.
: The datasets generated and/or analyzed during the current study are not publicly available because of pending regulatory submission and approval but may be available from the corresponding author on request.
: Not applicable.
: SK, LB, and SMB conceptualized and designed the study. SMB, LB, TB, JM, and XS designed and conducted the statistical analyses and vouch for the data. All authors were involved in the acquisition, analysis, or interpretation of the data. Under the guidance from all authors, medical writers Regina Switzer, PhD (paid for by Rebiotix Inc.), and Michelle Boland, PhD (ApotheCom, Yardley, PA, USA; paid for by Ferring Pharmaceuticals) assisted with the drafting of the manuscript. All authors provided critical revision of the manuscript, and all agreed to the submission of the manuscript.