Walk before you run: Feasibility challenges and lessons learned from the PROCLAIM study, a multicenter randomized controlled trial of misoprostol for prevention of recurrent C. difficile during COVID-19

We analyzed our challenging experience with a randomized controlled trial of misoprostol for preven-tion of recurrent C. difficile. Despite careful prescreening and thoughtful protocol modifications to facilitate enrollment, we closed the study early after enrolling just 7 participants over 3 years. We share lessons learned, noting the importance of feasibility studies, inclusion of biomarker outcomes, and dissemination of such findings to inform future research design and implementation successes.(c) 2023 Elsevier Ltd. All rights reserved.

Automated summary

We conducted a randomized controlled trial on the use of misoprostol for preventing recurrent C. difficile and analyzed our challenging experience. Despite careful screening and protocol modifications, the study was closed prematurely with only 7 participants enrolled over 3 years. We emphasize the importance of feasibility studies, inclusion of biomarker outcomes, and dissemination of findings for informing future research design and implementation successes.