Wilcox Mark H, McGovern Barbara H, Hecht Gail A
Department of Microbiology, Old Medical School, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
University of Leeds, Leeds, UK.
Open Forum Infect Dis. 2020 Apr 11;7(5):ofaa114. doi: 10.1093/ofid/ofaa114. eCollection 2020 May.
The leading risk factor for () infection (CDI) is broad-spectrum antibiotics, which lead to low microbial diversity, or dysbiosis. Current therapeutic strategies for CDI are insufficient, as they do not address the key role of the microbiome in preventing spore germination into toxin-producing vegetative bacteria, which leads to symptomatic disease. Fecal microbiota transplant (FMT) appears to reduce the risk of recurrent CDI through microbiome restoration. However, a wide range of efficacy rates have been reported, and few placebo-controlled trials have been conducted, limiting our understanding of FMT efficacy and safety. We discuss the current knowledge gaps driven by questions around the quality and consistency of clinical trial results, patient selection, diagnostic methodologies, use of suppressive antibiotic therapy, and methods for adverse event reporting. We provide specific recommendations for future trial designs of FMT to provide improved quality of the clinical evidence to better inform treatment guidelines.
艰难梭菌感染（CDI）的主要风险因素是广谱抗生素，这会导致微生物多样性降低，即生态失调。目前针对CDI的治疗策略并不充分，因为它们没有解决微生物群在防止孢子萌发成产毒素的营养细菌方面的关键作用，而这会导致出现症状性疾病。粪便微生物群移植（FMT）似乎通过恢复微生物群来降低复发性CDI的风险。然而，已报道的有效率范围很广，且很少进行安慰剂对照试验，这限制了我们对FMT疗效和安全性的了解。我们讨论了围绕临床试验结果的质量和一致性、患者选择、诊断方法、抑制性抗生素治疗的使用以及不良事件报告方法等问题所导致的当前知识空白。我们为FMT未来的试验设计提供了具体建议，以提高临床证据的质量，从而更好地为治疗指南提供依据。
