Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy; Department of Medical and Surgical Sciences, UOC Gastroenterologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; Department of Medical and Surgical Sciences, UOC CEMAD Centro Malattie dell'Apparato Digerente, Medicina Interna e Gastroenterologia, Fondazione Policlinico Universitario Gemelli IRCCS, Rome, Italy.
Microbiology Unit, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
Microbes Infect. 2024 Jul-Aug;26(5-6):105341. doi: 10.1016/j.micinf.2024.105341. Epub 2024 Apr 26.
Fecal microbiota transplantation (FMT) is effective against recurrent Clostridioides difficile infection (rCDI), but its safety is jeopardized by the potential transmission of pathogens, so international guidelines recommend either a quarantine or a direct stool testing. Whereas reports of the quarantine-based approach are emerging, data on the direct testing-based approach are not available. Our aim is to report outcomes of a donor screening framework for FMT including direct stool testing. In this prospective cohort study, all donor candidates recruited at our FMT centre underwent a four-step screening process to be enrolled as actual donors. Each collected stool donation was then evaluated with a direct stool testing including a molecular assay for gut pathogens and a culture assay for multi-drug resistant organisms (MDRO). From January 2019 to June 2023, 72 of 227 candidates (32%) were considered eligible and provided 277 stool donations. Ninety-nine donations (36%) were discarded for positivity to intestinal pathogens, most commonly enteropathogenic Escherichia coli (n = 37) and Blastocystis hominis (n = 20). Overall, 337 stool aliquots were obtained from 165 approved donations. All suspensions were used for patients with rCDI, and no serious adverse events or clinically evident infections were observed at 12 weeks after procedures. In our study, screening of donor faeces including direct stool testing led to the discard of a considerable rate of stool donations but was also extremely safe. This approach may represent a reliable strategy to guarantee the safety of FMT programs, especially in countries with high prevalence of MDRO.
粪便微生物群移植（FMT）对复发性艰难梭菌感染（rCDI）有效，但由于潜在的病原体传播风险，其安全性受到威胁，因此国际指南建议进行检疫或直接粪便检测。虽然基于检疫的方法的报告已经出现，但基于直接检测的方法的数据尚不可用。我们的目的是报告包括直接粪便检测在内的 FMT 供体筛选框架的结果。在这项前瞻性队列研究中，我们 FMT 中心招募的所有供体候选者都经过了四步筛选过程，以被纳入实际供体。然后，每个收集的粪便捐赠都通过直接粪便检测进行评估，包括肠道病原体的分子检测和多药耐药菌（MDRO）的培养检测。从 2019 年 1 月至 2023 年 6 月，227 名候选人中有 72 名（32%）被认为符合条件并提供了 277 份粪便捐赠。99 份捐赠物（36%）因肠道病原体阳性而被丢弃，最常见的是肠致病性大肠杆菌（n=37）和人芽囊原虫（n=20）。总体而言，从 165 份批准的捐赠物中获得了 337 个粪便等分试样。所有混悬液均用于治疗 rCDI 患者，并且在程序后 12 周内未观察到严重不良事件或临床明显感染。在我们的研究中，包括直接粪便检测在内的供体粪便筛查导致相当一部分粪便捐赠物被丢弃，但也非常安全。这种方法可能代表了一种可靠的策略，可以保证 FMT 项目的安全性，尤其是在 MDRO 流行率较高的国家。
