Table 1: Clinical Trials Comparing Investigational FMT and Standard Antibiotic Treatment

van Nood E, et al. 2013 Open-label, randomized, controlled trial between three groups: FMT with bowel lavage; vancomycin only; and vancomycin with bowel lavage Naso-duodenal in 41 patients who had recurrence of CDI after at least one course of antibiotic therapy Primary cure rate: FMT with bowel lavage=81%; Vancomycin (control)=31%; Vancomycin with bowel lavage (control)=23%; p<0.001; 99.9% CI
Cammarota G, et al. 2015 Open-label, randomized trial between FMT and vancomycin Colonoscopy in 39 patients who had recurrence of CDI after at least one course of antibiotic therapy Primary cure rate: FMT=90%; Vancomycin (control)= 26%; p<0.001; 99.9% CI
Kelly C, et al. 2016 Multicenter, double-blind, randomized trial between FMT with non-autologous and autologous donors Colonoscopy in 46 patients with three or more occurrences of CDI Primary cure rate: Non-autologous FMT=91% ; Autologous FMT (placebo)=63% p=0.24
Hvas C, et al. 2019 Open-label, randomized trial between vancomycin followed by FMT, vancomycin alone, and fidaxomicin alone. Colonoscopy or nasojejunal tube in 64 patients who had recurrence of CDI after at least one course of antibiotic therapy Primary cure rate: Vancomycin followed by FMT=92%; Vancomycin alone=19%; Fidaxomicin alone=42%; p<0.0001 (Vancomycin followed by FMT vs. Vancomycin alone); p<0.0002 (Vancomycin followed by FMT vs. Fidaxomicin alone)

Table 2: Observational Studies, Systematic Reviews, and Meta-Analyses

Kassam Z, et al. 2013 Statistical analysis of 11 studies (no randomized controlled trials) Various FMT modalities in 273 CDI patients Overall cure rate=89.7%
Cammarota G, et al. 2014 Statistical analysis of 20 case series, 15 case reports, and one randomized controlled study Various FMT modalities in 536 patients, “almost all” with recurrent CDI Overall cure rate=87%; Site of infusion: Stomach=81%; Duodenum/jejunum=86%; Cecum/ascending colon=93%; Distal Colon=84%
Drekonja D, et al. 2015 Statistical analysis of two randomized control trials, 28 case-series studies, and five case reports Various FMT modalities in 516 adult patients with CDI Overall cure rate=85%
Moayyedi P, et al. 2017 Statistical analysis of 10 randomized controlled trials Various FMT modalities in 657 CDI patients FMT was statistically significantly more effective than autologous or placebo. (RR, 0.41; 95% CI, 0.22-0.74)
Quraishi MN, et al. 2017 Statistical analysis of 37 studies: seven randomized controlled trials and thirty 30 case series Various FMT modalities in 1973 CDI patients. 428 enrolled in randomized controlled trials, 1545 in case series Overall cure rate=92% (95% CI); Lower delivery=95% (95% CI); Upper delivery=88% (95% CI); p=0.02
Braunwall SMD, et al. 2020 Statistical analysis of 45 observational studies and clinical trials Various FMT modalities. 2937 CDI patients received a single FMT. 1855 patients received repeat FMTs Repeat FMT cure rate=91%; Single FMT cure rate=84%
Osman M, et al. 2022 Statistical analysis of patient-level outcomes data gathered from a prospective, real-world observational cohort study Various FMT modalities across 5,344 CDI patients treated across 681 healthcare facilities The clinical cure rate from physician-reported outcomes across all delivery modalities and CDI types was 78% (4195 of 5344; 95% CI, 77%–80%). The subtype with the highest cure rate was recurrent CDI subtype (81%; 95% CI, 80%–83%). Lower delivery was reported as the most effective delivery route, with a reported cure rate of 81% (95% CI, 80%–82%)
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