Effect of Fecal Microbiota Transplantation on Recurrence in Multiply Recurrent Clostridium difficile Infection: A Randomized Trial.
Effect of Fecal Microbiota Transplantation on Recurrence in Multiply Recurrent Clostridium difficile Infection: A Randomized Trial.
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DOI：
10.7326/m16-0271
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发表时间：
2016-11-01
影响因子：
39.2
通讯作者：
Brandt LJ
中科院分区：
文献类型：
--
作者：
Kelly CR;Khoruts A;Staley C;Sadowsky MJ;Abd M;Alani M;Bakow B;Curran P;McKenney J;Tisch A;Reinert SE;Machan JT;Brandt LJ
迄今为止，粪便微生物群移植（FMT）对复发性艰难梭菌感染（CDI）有效性的证据仅限于病例系列和开放标签临床试验。确定 FMT 治疗复发性 CDI 的有效性和安全性。随机、对照、双盲临床试验。 （ClinicalTrials.gov：NCT01703494）两个学术医疗中心。 46 名患有 3 次或以上 CDI 复发且最近一次急性发作接受完整疗程万古霉素治疗的患者。通过结肠镜检查使用供体粪便（异源）或患者自身粪便（自体）进行粪便微生物群移植。主要终点是在 8 周随访期间腹泻得到缓解，无需进一步抗 CDI 治疗。通过审查 FMT 后 6 个月的不良事件 (AE)、严重 AE (SAE) 和新的医疗状况，比较治疗组之间的安全性数据。对 FMT 之前和之后的患者粪便以及捐赠者的粪便进行了粪便微生物群分析。在意向治疗分析中，供体 FMT 组 22 名患者中有 20 名（90.9%）获得临床治愈，而自体 FMT 组 24 名患者中有 15 名（62.5%）获得临床治愈（P = 0.042）。自体 FMT 后的分辨率因部位而异（10 个中的 9 个与 14 个中的 6 个 [P = 0.033]）。所有 9 名在自体 FMT 后出现复发性 CDI 的患者在随后的供体 FMT 后均未出现进一步的 CDI。没有发生与 FMT 相关的 SAE。供体 FMT 恢复了肠道细菌群落的多样性和组成，使其与健康供体相似。该研究仅纳入复发 3 次或以上的患者，排除免疫功能低下且年龄在 75 岁或以上的患者。通过结肠镜检查给予供体粪便似乎是安全的，并且在预防进一步的 CDI 发作方面比自体 FMT 更有效。国家糖尿病、消化系统和肾脏疾病研究所。
To date, evidence for the efficacy of fecal microbiota transplantation (FMT) in recurrent Clostridium difficile infection (CDI) has been limited to case series and open-label clinical trials. To determine the efficacy and safety of FMT for treatment of recurrent CDI. Randomized, controlled, double-blind clinical trial. (ClinicalTrials.gov: NCT01703494) Two academic medical centers. 46 patients who had 3 or more recurrences of CDI and received a full course of vancomycin for their most recent acute episode. Fecal microbiota transplantation with donor stool (heterologous) or patient’s own stool (autologous) administered by colonoscopy. The primary end point was resolution of diarrhea without the need for further anti-CDI therapy during the 8-week follow-up. Safety data were compared between treatment groups via review of adverse events (AEs), serious AEs (SAEs), and new medical conditions for 6 months after FMT. Fecal microbiota analyses were performed on patients’ stool before and after FMT and also on donors’ stool. In the intention-to-treat analysis, 20 of 22 patients (90.9%) in the donor FMT group achieved clinical cure compared with 15 of 24 (62.5%) in the autologous FMT group (P = 0.042). Resolution after autologous FMT differed by site (9 of 10 vs. 6 of 14 [P = 0.033]). All 9 patients who developed recurrent CDI after autologous FMT were free of further CDI after subsequent donor FMT. There were no SAEs related to FMT. Donor FMT restored gut bacterial community diversity and composition to resemble that of healthy donors. The study included only patients who had 3 or more recurrences and excluded those who were immunocompromised and aged 75 years or older. Donor stool administered via colonoscopy seemed safe and was more efficacious than autologous FMT in preventing further CDI episodes. National Institute of Diabetes and Digestive and Kidney Diseases.