Drekonja Dimitri M, Shaukat Aasma, Huang Yuan, Zhang Jane H, Reinink Andrew R, Nugent Sean, Dominitz Jason A, Davis-Karim Anne, Gerding Dale N, Kyriakides Tassos C
Division of Infectious Diseases, Department of Medicine, Minneapolis Veterans Affairs Health Care System, Minnesota, USA.
Division of Gastroenterology, Department of Medicine, New York Harbor Veterans Affairs Healthcare System, New York, USA.
Clin Infect Dis. 2025 Feb 5;80(1):52-60. doi: 10.1093/cid/ciae467.
Clostridioides difficile infection (CDI) is the most common cause of healthcare-associated infections in US hospitals, with 15%-30% of patients experiencing recurrence. The aim of our randomized, double-blind clinical trial was to assess the efficacy of capsule-delivered fecal microbiota transplant (FMT) versus placebo in reducing recurrent diarrhea and CDI recurrence. The secondary aim was FMT safety assessment.
Between 2018 and 2022, Veterans across the Veterans Health Administration system with recurrent CDI who responded to antibiotic treatment were randomized in a 1:1 ratio to oral FMT or placebo capsules. Randomization was stratified by number of prior CDI recurrences (1 or ≥2). The primary endpoint was clinical recurrence by day 56, defined as >3 unformed stools daily for ≥2 days with or without laboratory confirmation of C. difficile, or death within 56 days.
The study was stopped due to futility after meeting prespecified criteria. Of 153 participants (76 FMT, 77 placebo) with an average age of 66.5 years, 25 participants (32.9%) in the FMT arm and 23 (29.9%) in the placebo arm experienced the primary endpoint of diarrhea and possible or definite CDI recurrence or death within 56 days of capsule administration (absolute difference, 3.0% [95% confidence interval, -11.7% to 17.7%]). Stratification by number of recurrences revealed no statistically significant differences. There were no clinically important differences in adverse events.
FMT therapy versus placebo did not reduce CDI recurrence or death at 56 days. There were no meaningful differences in adverse events between treatment groups.
NCT03005379.
艰难梭菌感染（CDI）是美国医院医疗相关感染的最常见原因，15% - 30%的患者会复发。我们这项随机、双盲临床试验的目的是评估胶囊递送的粪便微生物群移植（FMT）与安慰剂相比在减少复发性腹泻和CDI复发方面的疗效。次要目的是评估FMT的安全性。
在2018年至2022年期间，退伍军人健康管理系统中对抗生素治疗有反应的复发性CDI退伍军人按1:1比例随机分为口服FMT组或安慰剂胶囊组。随机分组按既往CDI复发次数（1次或≥2次）进行分层。主要终点是至第56天的临床复发，定义为连续≥2天每天有>3次不成形粪便，无论有无艰难梭菌的实验室确认，或在56天内死亡。
在达到预先设定的标准后，该研究因无效而提前终止。153名参与者（76名FMT组，77名安慰剂组）的平均年龄为66.5岁，FMT组有25名参与者（32.9%），安慰剂组有23名参与者（29.9%）在服用胶囊后56天内经历了腹泻以及可能或确定的CDI复发或死亡的主要终点（绝对差异为3.0% [95%置信区间，-11.7%至17.7%]）。按复发次数分层显示无统计学显著差异。不良事件在临床上无重要差异。
FMT治疗与安慰剂相比，在56天时并未降低CDI复发率或死亡率。治疗组之间不良事件无显著差异。
NCT03005379。
