Document is current
Any future updates will be listed below
-
Authors
Aroniadis, Olga C. https://orcid.org/0000-0001-6501-0769
Guthmueller, Beth
Dehlin, Kaitlin
Srivastava, Shivam
Feuerstadt, Paul
Lembo, Anthony
Weber, Horst C.
-
Clinical Trials BETA
Clinical trials referenced in this document:
nct03931941 at ClinicalTrials.govDocuments that mention this clinical trial
Safety and Efficacy of Fecal Microbiota, Live-jslm to Prevent Recurrent Clostridioides difficile Infection in Participants With Irritable Bowel Syndrome
https://doi.org/10.1007/s40121-025-01208-0
-
Funding
Funding for this research was provided by:
Ferring Pharmaceuticals, Inc.
- License Information
-
More Information
Article History
Received: 5 June 2025
Accepted: 24 July 2025
First Online: 10 August 2025
Declarations
:
: Olga C. Aroniadis and Horst C. Weber declare no competing interests. Beth Guthmueller and Shivam Srivastava are employees of Ferring Pharmaceuticals. Kaitlin Dehlin was an employee of Ferring Pharmaceuticals at the time this study was conducted and is a current employee of American Regent, Inc. Paul Feuerstadt has acted as a consultant for Merck & Co.; has served as a speaker for SERES Therapeutics and Ferring Pharmaceuticals; and has served on advisory boards for Probiotech, Seres Therapeutics, Ferring Pharmaceuticals, Sanofi, and Takeda Pharmaceuticals. Anthony Lembo has served on advisory boards or as a consultant for Atmo Biosciences, Vibrant Pharma Inc., Takeda Pharmaceuticals, Ironwood Pharmaceuticals, Ardelyx, GSK, and Evoke Pharma, Inc., and owns stock in Allurion, Johnson & Johnson, and Bristol Myers Squibb.
: PUNCH CD3-OLS was conducted across the US and Canada under a US FDA Investigational New Drug Application and a Health Canada Clinical Trial Application. This study was approved by the Advarra (Pro00035155) Central Institutional Review Board (IRB) and some of the participating sites also obtained approval of the protocol from their local IRB/research ethics board (Supplementary Table 1). The study was conducted in accordance with the ethical standards of the 1964 Declaration of Helsinki. Participants provided written informed consent to participate prior to initiation of any study procedures. Additional PUNCH CD3-OLS study details have been published previously [].
