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Effect of Oral Capsule– vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection
JAMA ( IF 120.7 ) Pub Date : 2017-11-28 , DOI: 10.1001/jama.2017.17077
Dina Kao 1 , Brandi Roach 1 , Marisela Silva 2 , Paul Beck 3 , Kevin Rioux 4 , Gilaad G. Kaplan 3 , Hsiu-Ju Chang 5 , Stephanie Coward 6 , Karen J. Goodman 1 , Huiping Xu 7 , Karen Madsen 1 , Andrew Mason 1 , Gane Ka-Shu Wong 8 , Juan Jovel 9 , Jordan Patterson 9 , Thomas Louie 2
Affiliation  

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. Objective To determine whether FMT by oral capsule is noninferior to colonoscopy delivery in efficacy. 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%. Interventions Participants were randomly assigned to FMT by capsule or by colonoscopy at a 1:1 ratio. 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). 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). 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. Trial Registration clinicaltrials.gov Identifier: NCT02254811

中文翻译:

口服胶囊与结肠镜检查提供的粪便微生物群移植对复发性艰难梭菌感染的影响

重要性 粪便微生物群移植 (FMT) 可有效预防复发性艰难梭菌感染 (RCDI)。然而,尚不清楚临床疗效是否因递送途径而异。目的确定口服胶囊FMT在疗效上是否不劣于结肠镜检查。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性、非盲法、随机试验。2014 年 10 月至 2016 年 9 月期间,共有 116 名成年 RCDI 患者入组,随访至 2016 年 12 月。非劣效性边际为 15%。干预措施 参与者通过胶囊或结肠镜检查以 1:1 的比例随机分配到 FMT。主要结果和措施 主要结果是 FMT 后 12 周未发生 RCDI 的患者比例。次要结果包括 (1) 严重和轻微的不良事件,(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) 1(一点也不不愉快)到 10(非常不愉快)的等级的患者感知和 1(最好)到 10(最差)的等级的满意度。结果 在随机分配的 116 名患者(平均 [SD] 年龄,58 [19] 岁;79 名女性 [68%])中,105 名(91%)完成了试验,其中 57 名患者随机分配至胶囊组,59 名患者分配至结肠镜检查组。在符合方案分析中,胶囊组 (51/53) 和结肠镜检查组 (50/52) 单次治疗后 RCDI 的预防率为 96.2%(差异,0%;单侧 95% CI, −6.1% 至无穷大;P < .001),满足非劣效性标准。每组中的一名患者死于与 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%,而结肠镜检查组为 12.5%。生活质量改善无显着组间差异。接受胶囊的参与者中,更大比例的人认为他们的体验“一点也不令人不快”(66% 对 44%;差异,22% [95% CI,3%-40%];P = .01)。结论和相关性 在患有 RCDI 的成人中,口服胶囊 FMT 在预防 12 周以上的复发感染方面并不逊于通过结肠镜检查。口服胶囊治疗可能是治疗 RCDI 的有效方法。试验注册clinicaltrials.gov 标识符:NCT02254811 胶囊组为 4%,结肠镜检查组为 12.5%。生活质量改善无显着组间差异。接受胶囊的参与者中,更大比例的人认为他们的体验“一点也不令人不快”(66% 对 44%;差异,22% [95% CI,3%-40%];P = .01)。结论和相关性 在患有 RCDI 的成人中,口服胶囊 FMT 在预防 12 周以上的复发感染方面并不逊于通过结肠镜检查。口服胶囊治疗可能是治疗 RCDI 的有效方法。试验注册clinicaltrials.gov 标识符:NCT02254811 胶囊组为 4%,结肠镜检查组为 12.5%。生活质量改善无显着组间差异。接受胶囊的参与者中,更大比例的人认为他们的体验“一点也不令人不快”(66% 对 44%;差异,22% [95% CI,3%-40%];P = .01)。结论和相关性 在患有 RCDI 的成人中,口服胶囊 FMT 在预防 12 周以上的复发感染方面并不逊于通过结肠镜检查。口服胶囊治疗可能是治疗 RCDI 的有效方法。试验注册clinicaltrials.gov 标识符:NCT02254811 接受胶囊的参与者中,更大比例的人认为他们的体验“一点也不令人不快”(66% 对 44%;差异,22% [95% CI,3%-40%];P = .01)。结论和相关性 在患有 RCDI 的成人中,口服胶囊 FMT 在预防 12 周以上的复发感染方面并不逊于通过结肠镜检查。口服胶囊治疗可能是治疗 RCDI 的有效方法。试验注册clinicaltrials.gov 标识符:NCT02254811 接受胶囊的参与者中,更大比例的人认为他们的体验“一点也不令人不快”(66% 对 44%;差异,22% [95% CI,3%-40%];P = .01)。结论和相关性 在患有 RCDI 的成人中,口服胶囊 FMT 在预防 12 周以上的复发感染方面并不逊于通过结肠镜检查。口服胶囊治疗可能是治疗 RCDI 的有效方法。试验注册clinicaltrials.gov 标识符:NCT02254811
更新日期:2017-11-28
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