Fecal Microbiota Transplantation Versus Vancomycin for Primary Clostridioides difficile Infection : A Randomized Controlled Trial.

IF 19.6 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

Annals of Internal Medicine Pub Date : 2025-06-17 DOI:10.7326/ANNALS-24-03285

Frederik Emil Juul, Michael Bretthauer, Peter H Johnsen, Faye Samy, Kristian Tonby, Jan Erik Berdal, Dag Arne L Hoff, Eirik H Ofstad, Awet Abraham, Birgitte Seip, Håvard Wiig, Øyvind Bakken Rognstad, Ida F Glad, Jørgen Valeur, Axel E Nissen-Lie, Eivind Ness-Jensen, Kristine M A Lund, Linn K Skjevling, Kurt Hanevik, Hilde Skudal, Ellen J Melsom, Raziye Boyar, Trond J Cooper, Trond E Ranheim, Esben M Riise, Hans-Olov Adami, Mette Kalager, Magnus Løberg, Kjetil K Garborg

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引用次数: 0

Abstract

Background: Fecal microbiota transplantation (FMT) is recommended for recurrent Clostridioides difficile infection (CDI), but its role in primary CDI is unclear.

Objective: To investigate the efficacy and safety of FMT in primary CDI.

Design: Randomized, open-label, noninferiority, multicenter trial. (ClinicalTrials.gov: NCT03796650).

Setting: Hospitals and primary care facilities in Norway.

Patients: Adults with CDI (C difficile toxin in stool and ≥3 loose stools daily) and no previous CDI within 365 days before enrollment.

Intervention: FMT without antibiotic pretreatment versus oral vancomycin, 125 mg 4 times daily for 10 days.

Measurements: The primary end point was clinical cure (firm stools or <3 bowel movements daily) at day 14 and no disease recurrence within 60 days with the assigned treatment alone.

Results: Of 104 randomly assigned patients, 100 received FMT or the first dose of vancomycin and were eligible for analysis. Clinical cure and no disease recurrence within 60 days without additional treatment was observed in 34 of 51 patients (66.7%) with FMT versus 30 of 49 (61.2%) with vancomycin (difference, 5.4 percentage points [95.2% CI, -13.5 to 24.4 percentage points]; P for noninferiority < 0.001, rejecting the hypothesis that response to FMT is 25 percentage points lower than response to vancomycin). Eleven patients in the FMT group and 4 in the vancomycin group had additional C difficile treatment. Clinical cure at day 14 and no recurrence with or without additional treatment was observed in 40 of 51 patients (78.4%) with FMT and 30 of 49 (61.2%) with vancomycin (difference, 17.2 percentage points [95.2% CI, -0.7 to 35.1 percentage points]). No significant differences in adverse events were observed between groups.

Limitations: Open-label design and reliance on clinical end points.

Conclusion: FMT may be considered as first-line therapy in primary CDI.

Primary funding source: South-East Norway Health Trust.

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粪便菌群移植与万古霉素治疗原发性艰难梭菌感染：一项随机对照试验。

背景：粪便微生物群移植（FMT）被推荐用于复发性艰难梭菌感染（CDI），但其在原发性CDI中的作用尚不清楚。目的：探讨FMT治疗原发性CDI的疗效和安全性。设计：随机、开放标签、非劣效性、多中心试验。(ClinicalTrials.gov: NCT03796650)。环境：挪威的医院和初级保健设施。患者：入组前365天内患有CDI（粪便中有C艰难梭菌毒素，每天≥3次稀便）且无CDI病史的成人。干预：不加抗生素预处理的FMT vs口服万古霉素，125 mg，每天4次，持续10天。测量：主要终点是临床治愈（坚定的粪便或结果）：在104名随机分配的患者中，100名接受了FMT或第一剂万古霉素治疗，符合分析条件。51例FMT患者中有34例（66.7%）临床治愈，无需额外治疗，60天内无疾病复发，49例万古霉素患者中有30例（61.2%）(差异5.4个百分点[95.2% CI, -13.5至24.4个百分点]；P表示非劣效性< 0.001，拒绝了FMT应答比万古霉素应答低25个百分点的假设)。FMT组11例患者和万古霉素组4例患者接受了额外的艰难梭菌治疗。51例FMT患者中有40例（78.4%）临床治愈，49例万古霉素患者中有30例（61.2%）临床治愈（差异为17.2个百分点[95.2% CI, -0.7 ~ 35.1个百分点]）。两组间不良事件发生率无显著差异。局限性：开放标签设计和对临床终点的依赖。结论：FMT可作为原发性CDI的一线治疗方法。主要资金来源：东南挪威卫生信托基金。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of Internal Medicine 医学-医学：内科

CiteScore

23.90

自引率

1.80%

发文量

1136

审稿时长

3-8 weeks

期刊介绍： Established in 1927 by the American College of Physicians (ACP), Annals of Internal Medicine is the premier internal medicine journal. Annals of Internal Medicine’s mission is to promote excellence in medicine, enable physicians and other health care professionals to be well informed members of the medical community and society, advance standards in the conduct and reporting of medical research, and contribute to improving the health of people worldwide. To achieve this mission, the journal publishes a wide variety of original research, review articles, practice guidelines, and commentary relevant to clinical practice, health care delivery, public health, health care policy, medical education, ethics, and research methodology. In addition, the journal publishes personal narratives that convey the feeling and the art of medicine.