Abstract

Importance:

Fecal microbiota transplantation (FMT) is effective in preventing recurrent Clostridium difficile infection (RCDI). However, it is not known whether clinical efficacy differs by route of delivery.

重要性：粪便微生物群移植（FMT）可有效预防复发性梭菌（Clostridium difficile）感染（RCDI）。然而，尚不清楚临床疗效是否因递送途径而出现差异。

Objective:

To determine whether FMT by oral capsule is noninferior to colonoscopy delivery in efficacy.

目的：确定口服的FMT是否不劣于结肠镜递送的疗效。

Design, Setting, and Participants:

Noninferiority, unblinded, randomized trial conducted in 3 academic centers in Alberta, Canada. A total of 116 adult patients with RCDI were enrolled between October 2014 and September 2016, with follow-up to December 2016. The noninferiority margin was 15%.

设计，设置和参与者：在加拿大艾伯塔省的3个学术中心进行的非劣效，非盲，随机试验。 2014年10月至2016年9月期间共有116名RCDI成年患者入组，随访至2016年12月。非劣效性边际为15％。

Interventions:

Participants were randomly assigned to FMT by capsule or by colonoscopy at a 1:1 ratio.

干预：参与者以1：1的比例随机分配通过胶囊或结肠镜进行粪便移植的治疗组。

Main Outcomes and Measures:

The primary outcome was the proportion of patients without RCDI 12 weeks after FMT. Secondary outcomes included (1) serious and minor adverse events, (2) changes in quality of life by the 36-Item Short Form Survey on a scale of 0 (worst possible quality of life) to 100 (best quality of life), and (3) patient perception on a scale of 1 (not at all unpleasant) to 10 (extremely unpleasant) and satisfaction on a scale of 1 (best) to 10 (worst).

主要结果和测量：主要结果是经FMT治疗12周后无RCDI的患者比例。次要结果包括（1）严重和轻微不良事件，（2）36项简表调查的生活质量变化，范围为0（可能的最差生活质量）至100（最佳生活质量），以及（3）患者主观感受评分：1（根本不愉快）至10（很不愉快），满意度为1（最佳）至10（最差）。

Results:

Among 116 patients randomized (mean [SD] age, 58 [19] years; 79 women [68%]), 105 (91%) completed the trial, with 57 patients randomized to the capsule group and 59 to the colonoscopy group. In per-protocol analysis, prevention of RCDI after a single treatment was achieved in 96.2% in both the capsule group (51/53) and the colonoscopy group (50/52) (difference, 0%; 1-sided 95% CI, -6.1% to infinity; P < .001), meeting the criterion for noninferiority. One patient in each group died of underlying cardiopulmonary illness unrelated to FMT. Rates of minor adverse events were 5.4% for the capsule group vs 12.5% for the colonoscopy group. There was no significant between-group difference in improvement in quality of life. A significantly greater proportion of participants receiving capsules rated their experience as "not at all unpleasant" (66% vs 44%; difference, 22% [95% CI, 3%-40%]; P = .01).

结果：随机分组的116名患者（平均年龄58；名女性[68％]），105名（91％）完成了试验，其中57名患者随机分到胶囊组，59名随机分组到结肠镜组。在按方案分析中，在两组（胶囊组（51/53）和结肠镜检查组（50/52））中，单次治疗后预防艰难梭菌率达96.2％，符合非劣效性标准。每组中有一名患者死于与FMT无关的潜在心肺疾病。胶囊组的轻微不良事件发生率为5.4％，结肠镜组为12.5％。生活质量改善之间没有显著组间差异。接受胶囊的参与者中有相当大比例的人将他们的经历称为“根本不令人不愉快”。

Conclusions and Relevance:

Among adults with RCDI, FMT via oral capsules was not inferior to delivery by colonoscopy for preventing recurrent infection over 12 weeks. Treatment with oral capsules may be an effective approach to treating RCDI.

结论和相关性：在患有RCDI的成人中，通过口服胶囊进行FMT并不逊于通过结肠镜来预防12周内艰难梭菌复发感染。口服胶囊治疗可能是治疗RCDI的有效方法。