{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T08:50:23Z","timestamp":1791276623890,"version":"4.1.0"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2026,6,20]],"date-time":"2026-06-20T00:00:00Z","timestamp":1781913600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003122","name":"Ferring Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003122","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Fecal microbiota, live (RBL) is a single-dose, broad consortium, microbiota-based product approved in the United States and Canada for preventing recurrent Clostridioides difficile (C. diff) infection in adults following standard-of-care (SOC) treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>PUNCH CD3-OLS was a phase 3, open-label, multicenter study evaluating safety and effectiveness of RBL in adults, including those with comorbidities, with recurrent C. diff infection. Participants were aged \u226518\u2009years, had recurrent C. diff infection (\u22651 recurrence\/\u22652 severe episodes; diagnostic method was site-specific), and received SOC antibiotics before rectal administration of RBL. The primary endpoint was treatment-emergent adverse events (TEAEs) through 6\u2009months post-administration. Secondary endpoints included treatment success at 8\u2009weeks and sustained clinical response at 6\u2009months. This subgroup analysis examined outcomes among Canadian participants across 5 sites.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 117 Canadian participants who received RBL, most were female and White, with a mean age of 61.3\u2009years; 24.8% reported a first recurrence. The enrolling C. diff infection was diagnosed via polymerase chain reaction for 70.9% of participants. TEAEs, reported in 59.8% of participants, were mostly mild-to-moderate gastrointestinal events. Serious TEAEs occurred in 5.1% of participants within 8\u2009weeks and 6.8% between 8\u2009weeks and 6\u2009months. Treatment success was achieved by 75.2% of participants at 8\u2009weeks, among whom 90.9% maintained a sustained clinical response at 6\u2009months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Safety and effectiveness outcomes in Canadian participants were consistent with those observed in the PUNCH CD3 randomized controlled trial population, supporting the use of RBL for prevention of recurrent C. diff infection in Canada.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>ClinicalTrials.gov identifier<\/jats:title>\n                    <jats:p>NCT03931941.<\/jats:p>\n                  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