Retrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTA) administered by colonoscopy under enforcement discretion for the prevention of recurrent infection.

Background: Fecal microbiota, live-jslm (RBL; REBYOTA), is the first Food and Drug Administration (FDA)-approved, single-dose, rectally administered, microbiota-based live biotherapeutic product for preventing infection (CDI) recurrence. Alternative routes of administration are of clinical interest.

Objectives: Evaluate the safety and efficacy of RBL administration colonoscopy.

Retrospective Analysis of the Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA) Administered Under Enforcement Discretion to Patients With Infection.

Background: Fecal microbiota, live-jslm (RBL; REBYOTA™), the first microbiota-based live biotherapeutic approved by the US Food and Drug Administration to prevent recurrent infection (rCDI) in adults, has been evaluated in 5 prospective clinical trials. A retrospective analysis considered the safety and efficacy of RBL administered under US Food and Drug Administration enforcement discretion to patients with rCDI and broad eligibility criteria mimicking real-world practice.

Methods: We retrospectively identified adults with rCDI treated with RBL under enforcement discretion between November 1, 2015, and September 30, 2019, across 5 study sites.

Diverticular disease-associated segmental colitis.

Diverticular disease-associated segmental colitis is a unique variant of chronic colitis limited to segments of the left colon that harbor diverticula. Histologically, this disease mimics chronic idiopathic inflammatory bowel disease and can be indistinguishable from ulcerative colitis or Crohn's colitis on histologic grounds alone. Patients typically present with hematochezia and cramping abdominal pain, and colonoscopic evaluation reveals inflammatory changes limited to the segment of bowel containing the diverticula, with rectal sparing.