Fecal Microbiota Transplant for Relapsing Clostridium difficile Infection Using a Frozen Inoculum From Unrelated Donors: A Randomized, Open-Label, Controlled Pilot Study
Fecal Microbiota Transplant for Relapsing Clostridium difficile Infection Using a Frozen Inoculum From Unrelated Donors: A Randomized, Open-Label, Controlled Pilot Study
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DOI：
10.1093/cid/ciu135
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发表时间：
2014-06-01
影响因子：
11.8
通讯作者：
Hohmann, Elizabeth L.
中科院分区：
文献类型：
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作者：
Youngster, Ilan;Sauk, Jenny;Hohmann, Elizabeth L.
背景。复发性艰难梭菌感染 (CDI) 对标准抗菌治疗反应不佳是一个日益严重的医学问题。我们的目的是通过比较结肠镜和鼻胃管 (NGT) 给药，研究使用无关捐赠者的冷冻悬浮液进行粪便微生物群移植 (FMT) 治疗复发性 CDI 的结果。方法。对健康志愿者捐赠者进行筛选并生成冷冻粪便悬浮液。复发/难治性 CDI 患者被随机分配接受通过结肠镜检查或 NGT 输注供体粪便。主要终点是8周后腹泻的临床缓解且没有复发。次要终点是使用标准化问卷自我报告的健康评分。结果。共有 20 名患者入组，每个治疗组 10 名。在研究入组之前，患者中位数有 4 次（范围，2-16）次复发，其中 5 次（范围，3-15）次抗生素治疗失败。 14 名患者 (70%) 在单次 FMT 后腹泻得到缓解（结肠镜检查组 10 名患者中有 8 名，NGT 组 10 名患者中有 6 名）。治疗5例，治愈4例，总治愈率90%。每日排便次数从 FMT 前一天的中位数 7 次（四分位距 [IQR]，5-10）变为输注后的 2 次（IQR，1-2）。自评健康评分显着改善，从移植前的中位数 4（IQR，2-6）提高到移植后的 8（IQR，5-9）。没有发生严重或意外的不良事件。结论。在我们最初的可行性研究中，使用来自无关捐赠者的冷冻接种物进行 FMT 可有效治疗复发性 CDI。 NGT 给药似乎与结肠镜给药一样有效。
Background. Recurrent Clostridium difficile infection (CDI) with poor response to standard antimicrobial therapy is a growing medical concern. We aimed to investigate the outcomes of fecal microbiota transplant (FMT) for relapsing CDI using a frozen suspension from unrelated donors, comparing colonoscopic and nasogastric tube (NGT) administration.Methods. Healthy volunteer donors were screened and a frozen fecal suspension was generated. Patients with relapsing/refractory CDI were randomized to receive an infusion of donor stools by colonoscopy or NGT. The primary endpoint was clinical resolution of diarrhea without relapse after 8 weeks. The secondary endpoint was self-reported health score using standardized questionnaires.Results. A total of 20 patients were enrolled, 10 in each treatment arm. Patients had a median of 4 (range, 2-16) relapses prior to study enrollment, with 5 (range, 3-15) antibiotic treatment failures. Resolution of diarrhea was achieved in 14 patients (70%) after a single FMT (8 of 10 in the colonoscopy group and 6 of 10 in the NGT group). Five patients were retreated, with 4 obtaining cure, resulting in an overall cure rate of 90%. Daily number of bowel movements changed from a median of 7 (interquartile range [IQR], 5-10) the day prior to FMT to 2 (IQR, 1-2) after the infusion. Self-ranked health score improved significantly, from a median of 4 (IQR, 2-6) before transplant to 8 (IQR, 5-9) after transplant. No serious or unexpected adverse events occurred.Conclusions. In our initial feasibility study, FMT using a frozen inoculum from unrelated donors is effective in treating relapsing CDI. NGT administration appears to be as effective as colonoscopic administration.