Department of Internal Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
Recurrent Clostridium difficile infection is difficult to treat, and failure rates for antibiotic therapy are high. We studied the effect of duodenal infusion of donor feces in patients with recurrent C. difficile infection.
We randomly assigned patients to receive one of three therapies: an initial vancomycin regimen (500 mg orally four times per day for 4 days), followed by bowel lavage and subsequent infusion of a solution of donor feces through a nasoduodenal tube; a standard vancomycin regimen (500 mg orally four times per day for 14 days); or a standard vancomycin regimen with bowel lavage. The primary end point was the resolution of diarrhea associated with C. difficile infection without relapse after 10 weeks.
The study was stopped after an interim analysis. Of 16 patients in the infusion group, 13 (81%) had resolution of C. difficile-associated diarrhea after the first infusion. The 3 remaining patients received a second infusion with feces from a different donor, with resolution in 2 patients. Resolution of C. difficile infection occurred in 4 of 13 patients (31%) receiving vancomycin alone and in 3 of 13 patients (23%) receiving vancomycin with bowel lavage (P<0.001 for both comparisons with the infusion group). No significant differences in adverse events among the three study groups were observed except for mild diarrhea and abdominal cramping in the infusion group on the infusion day. After donor-feces infusion, patients showed increased fecal bacterial diversity, similar to that in healthy donors, with an increase in Bacteroidetes species and clostridium clusters IV and XIVa and a decrease in Proteobacteria species.
The infusion of donor feces was significantly more effective for the treatment of recurrent C. difficile infection than the use of vancomycin. (Funded by the Netherlands Organization for Health Research and Development and the Netherlands Organization for Scientific Research; Netherlands Trial Register number, NTR1177.).
复发性艰难梭菌感染难以治疗，抗生素治疗的失败率很高。我们研究了供体粪便十二指肠输注在复发性艰难梭菌感染患者中的疗效。
我们将患者随机分为三组接受治疗：初始万古霉素治疗方案（500mg 口服，每日 4 次，连用 4 天），随后行肠道灌洗，随后通过鼻肠管输注供体粪便溶液；标准万古霉素治疗方案（500mg 口服，每日 4 次，连用 14 天）；或标准万古霉素治疗方案加肠道灌洗。主要终点是在 10 周后无艰难梭菌感染相关性腹泻复发的情况下缓解腹泻。
在中期分析后，研究提前停止。在输注组的 16 例患者中，13 例（81%）在第一次输注后艰难梭菌相关腹泻得到缓解。其余 3 例患者接受了来自不同供体粪便的第二次输注，其中 2 例缓解。单独使用万古霉素治疗的 13 例患者中有 4 例（31%）和使用万古霉素加肠道灌洗治疗的 13 例患者中有 3 例（23%）艰难梭菌感染得到缓解（与输注组相比，差异均具有统计学意义 P<0.001）。除输注组在输注日出现轻度腹泻和腹痛外，三组患者的不良事件无显著差异。供体粪便输注后，患者粪便细菌多样性增加，类似于健康供体，拟杆菌门和梭菌簇 IV 和 XIVa 增加，变形菌门减少。
与使用万古霉素相比，供体粪便输注治疗复发性艰难梭菌感染的效果显著更优。（由荷兰健康研究与发展组织和荷兰科学研究组织资助；荷兰临床试验注册编号：NTR1177。）
