Background & Aims

Fecal microbiota transplantation (FMT) emerged as rescue treatment for multiply recurrent Clostridioides difficile infections (rCDIs) nonresponsive to standard therapy. However, estimation of FMT efficacy varies among different protocols and formulations, while placebo-controlled clinical trials have excluded most rCDI patients because of medical comorbidities. This study aimed to determine the safety and effectiveness of capsule FMT (cap-FMT) and colonoscopy FMT (colo-FMT) for rCDI using standardized products in a large, multicenter, prospective, real-world cohort.

Methods

Clinical outcomes and adverse events after FMT performed for rCDI at 6 sites were captured in a prospective registry. FMT was performed using 1 of 2 standardized formulations of microbiota manufactured by the University of Minnesota Microbiota Therapeutics Program, freeze-dried/encapsulated or frozen-thawed/liquid. The FMT administration route was determined by the treating physician. The rCDI cure rate was assessed at 1 and 2 months. Safety data were collected within the first 72 hours and at 1 and 2 months. Logistic regression was used to investigate factors associated with FMT failure.

Results

A total of 301 FMTs were performed in 269 unique patients. Two-thirds were cap-FMT. CDI cure rates were 86% (95% CI, 82%–90%) at 1 month and 81% (95% CI, 75%–86%) at 2 months. There was no difference in the 1-month or 2-month cure rate between cap-FMT and colo-FMT. Cap-FMT recipients were older and less likely to be immunosuppressed or have inflammatory bowel disease. Patient factors of older age and hemodialysis were associated with FMT failure by 2 months on multivariate logistic regression. In addition, post-FMT antibiotic use was associated with FMT failure at 2 months. One serious adverse event was related to colonoscopy (aspiration pneumonia), otherwise no new safety signals were identified.

Conclusions

Cap-FMT using freeze-dried capsules has a similar safety and effectiveness profile compared with colo-FMT, without the procedural risks of colonoscopy. Although highly effective overall, patient selection is a key factor to optimizing FMT success.

中文翻译：

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结肠和荚膜粪便微生物群移植治疗复发性艰难梭菌感染的有效性和安全性

 背景与目标

粪便微生物群移植（FMT）作为对标准治疗无反应的多发复发性艰难梭菌感染（rCDI）的救援治疗而出现。然而，不同方案和配方对 FMT 疗效的估计各不相同，而安慰剂对照临床试验由于医疗合并症而排除了大多数 rCDI 患者。本研究旨在通过大型、多中心、前瞻性、真实世界队列，使用标准化产品确定胶囊 FMT (cap-FMT) 和结肠镜 FMT (colo-FMT) 对 rCDI 的安全性和有效性。

 方法

在 6 个地点针对 rCDI 进行 FMT 后的临床结果和不良事件记录在前瞻性登记中。使用明尼苏达大学微生物群治疗计划生产的 2 种标准化微生物制剂中的一种（冻干/封装或冻融/液体）进行 FMT。 FMT 给药途径由治疗医生决定。在 1 个月和 2 个月时评估 rCDI 治愈率。在最初 72 小时内以及 1 个月和 2 个月内收集安全数据。使用逻辑回归来研究与 FMT 失败相关的因素。

 结果

总共对 269 名独特患者进行了 301 次 FMT。三分之二的人接受了上限 FMT。 1 个月时 CDI 治愈率为 86%（95% CI，82%–90%），2 个月时为 81%（95% CI，75%–86%）。 cap-FMT 和 colo-FMT 的 1 个月或 2 个月治愈率没有差异。 Cap-FMT 接受者年龄较大，免疫抑制或患有炎症性肠病的可能性较小。多元逻辑回归显示，患者年龄较大和血液透析等因素与 FMT 2 个月失败相关。此外，FMT 后抗生素的使用与 2 个月时 FMT 失败相关。一项严重不良事件与结肠镜检查（吸入性肺炎）有关，否则没有发现新的安全信号。

 结论

与 colo-FMT 相比，使用冻干胶囊的 Cap-FMT 具有相似的安全性和有效性，且没有结肠镜检查的操作风险。虽然总体上非常有效，但患者选择是优化 FMT 成功的关键因素。