Patient Preference and Adherence (Aug 2023)
Patient Perception of Route of Rectal Administration of Live Biotherapeutic Product for Recurrent Clostridioides difficile Infection
Abstract
Paul Feuerstadt,1,2 Caterina Oneto,3,4 Glenn Tillotson,5 Nicholas W Van Hise6 1Division of Digestive Disease, Yale School of Medicine, New Haven, CT, USA; 2PACT Gastroenterology Center, Hamden, CT, USA; 3Department of Medicine, New York University Langone, New York, NY, USA; 4Vanguard Gastroenterology, New York, NY, USA; 5GST Micro LLC, North, VA, USA; 6Metro Infectious Disease Consultants, Burr Ridge, IL, USACorrespondence: Glenn Tillotson, GST Micro LLC, 327 Plantation Road, North, VA, 23128, USA, Tel +1 858 361 3613, Email [email protected]: CDI is a recurrent disease that is treated with antibiotics, but patients commonly experience repeat infections with significant impacts on hospital budgets and patient health quality. Standard of care management includes the antibiotics, vancomycin and fidaxomicin, which frequently provide clinical response, but do not avoid recurrence of Clostridioides difficile infection (rCDI). These recurrent infections occur due to dysbiosis of the colonic microbiota. One adjunctive therapeutic approach is to restore the deficient gastrointestinal flora using fecal microbiota transplantation (FMT) or live biotherapeutic products (LBP) when given after standard of care antimicrobials, which have been successful in reducing repeat infections with success rates up to 88%. FMT or LBP can be given by various routes.Methods: Two groups of subjects aged ≥ 18 years with at least one previous CDI episode within the previous 36 months completed self-administered online surveys to assess the acceptability of an LBP administered rectally. Group 1 consisted of LBP-recipients who had received RBL (REBYOTA) rectally as part of the Phase III PUNCH CD3 clinical trial. Group 2 consisted of LBP-naïve subjects who volunteered to participate and had experienced CDI within the prior 36 months but had no history of receiving FMT or LBP therapy.Results: LBP-recipients considered rectal administration easy (96%) and quick (94%), while 98% of respondents considered the lack of need for bowel preparation appealing. Most LBP-recipients (96%) wished they had earlier access to RBL. Most LBP-naïve subjects (87%) were likely or somewhat likely to consider a rectally administered treatment and 80% preferred a treatment option that does not require bowel preparation. Many of these subjects (76%) expressed interest in finding out about new treatment options for rCDI.Discussion: LBP-recipients and LBP-naïve subjects alike felt that rectal delivery of microbiome therapy is not only acceptable but highly interesting as a treatment avenue.Plain Language Summary: Fecal microbiota transplantation (FMT) and live biotherapeutic products (LBP) are emerging as treatment options for recurrent infections. These products can be administered rectally. While LBP are screened and standardized products, FMT products are not. Patients with recurrent Clostridioides difficile infection considered the rectal route of delivery to be quick, convenient, acceptable, and lacking issues such as need for bowel preparation.Keywords: Clostridioides difficile infection, patient preference, quality of life, fecal microbiota transplant, live biotherapeutic product
