Outcomes After Fecal Microbiota Transplantation in Combination With Bezlotoxumab for Inflammatory Bowel Disease and Recurrent Clostridioides difficile Infection.
Jessica R AllegrettiJordan E AxelradRahul S DalalColleen R KellyAri GrinspanMonika FischerPublished in: The American journal of gastroenterology (2024)
Fecal microbiota transplantation (FMT) prevents recurrent Clostridioides difficile infections (rCDI) in patients with inflammatory bowel disease. Bezlotoxumab is also indicated to prevent rCDI. We assess the impact of FMT in combination with bezlotoxumab in patients with inflammatory bowel disease and rCDI. We conducted a multicenter randomized placebo-controlled trial. All received a single colonoscopic FMT. Patients were randomized 1:1 to receive bezlotoxumab or placebo. Sixty-one patients were enrolled (30 received treatment and 31 received placebo). Overall, 5 participants (8%) experienced a CDI recurrence; 4 in the treatment arm, 1 in the placebo arm (13% vs 3%, P = 0.15). There was no clear benefit to the combination approach compared with FMT alone.
Keyphrases
- double blind
- patients with inflammatory bowel disease
- end stage renal disease
- placebo controlled
- phase iii
- newly diagnosed
- ejection fraction
- clostridium difficile
- chronic kidney disease
- clinical trial
- open label
- prognostic factors
- peritoneal dialysis
- randomized controlled trial
- stem cells
- bone marrow
- cell therapy
- mouse model
- ulcerative colitis