Department of Medical Microbiology, Leiden University Medical Center, Leiden, Netherlands.
Department of Medical Microbiology, Leiden University Medical Center, Leiden, Netherlands.
Lancet Infect Dis. 2021 May;21(5):711-721. doi: 10.1016/S1473-3099(20)30473-4. Epub 2020 Dec 1.
On June 13, 2019, the US Food and Drug Administration issued a warning after transfer of faeces containing an extended-spectrum β-lactamase (ESBL)-producing Escherichia coli by faecal microbiota transplantation led to bacteraemia in two immunocompromised patients. Consequently, we evaluated the effectiveness of the faeces donor-screening protocol of the Netherlands Donor Faeces Bank, which consists of screening of donors for multidrug-resistant organisms every 3 months, combined with additional screening on indication (eg, after travelling abroad) and application of a quarantine period for all faecal suspensions delivered within those 3 months.
We did a retrospective cohort study of data collected between Jan 1, 2015, and Oct 14, 2019, on the multidrug-resistant organism testing results of donor faeces. Additionally, we tested previously quarantined faecal suspensions approved for faecal microbiota transplantation between Dec 12, 2016, and May 1, 2019, for the presence of multidrug-resistant organisms using both aselective and selective broth enrichment media. Whole-genome sequencing with core-genome multilocus sequence typing (cgMLST) was done on all multidrug-resistant isolates.
Among initial screenings, six (9%) of 66 tested individuals were positive for multidrug-resistant organisms and 11 (17%) of 66 tested individuals were positive for multidrug-resistant organisms at any timepoint. Multidrug-resistant organisms were detected in four (25%) of 16 active donors, who had a median donation duration of 268 days (IQR 92 to 366). Among all screening results, 14 (74%) of 19 detected multidrug-resistant organisms were ESBL-producing E coli. 170 (49%) of 344 approved faecal suspensions had corresponding research faeces aliquots available and were tested (from 11 active donors with a median of eight [IQR five to 26] suspensions per donor). No multidrug-resistant organisms were detected in the 170 approved faecal suspensions (one-sided 95% CI 0 to 1·7). cgMLST revealed that all multidrug-resistant organisms were genetically different.
Healthy faeces donors can become colonised with multidrug-resistant organisms during donation activities. Our screening protocol did not result in approval of multidrug-resistant organism-positive faecal suspensions for microbiota transplantation.
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2019 年 6 月 13 日，美国食品和药物管理局发出警告，此前通过粪便微生物群移植转移产超广谱β-内酰胺酶（ESBL）的大肠杆菌导致两名免疫功能低下的患者发生菌血症。因此，我们评估了荷兰粪便捐赠银行的粪便供体筛查方案的有效性，该方案包括每 3 个月筛查一次多药耐药菌，以及在有指征时（例如，出国旅行后）进行额外筛查，并对这 3 个月内交付的所有粪便悬液实行检疫期。
我们对 2015 年 1 月 1 日至 2019 年 10 月 14 日期间收集的关于供体粪便中多药耐药菌检测结果的数据进行了回顾性队列研究。此外，我们使用选择性和选择性肉汤富集培养基对 2016 年 12 月 12 日至 2019 年 5 月 1 日期间获准用于粪便微生物群移植的先前检疫粪便悬液进行了多药耐药菌检测。对所有多药耐药分离株进行全基因组测序和核心基因组多位点序列分型（cgMLST）。
在初始筛查中，66 名检测者中有 6 名（9%）对多药耐药菌呈阳性，66 名检测者中有 11 名（17%）在任何时间点对多药耐药菌呈阳性。在 4 名（25%）活跃供体中检测到多药耐药菌，他们的中位捐赠时间为 268 天（IQR 92 至 366）。在所有筛查结果中，19 种检测到的多药耐药菌中有 14 种（74%）为产 ESBL 的大肠杆菌。170 个（49%）批准的粪便悬液有相应的研究粪便等分试样可供检测（来自 11 名活跃的供体，每名供体的平均数量为 8 个[IQR 5 至 26]）。在 170 个批准的粪便悬液中未检测到多药耐药菌（单侧 95%CI 0 至 1.7）。cgMLST 显示，所有多药耐药菌在遗传上均不同。
健康的粪便供体在捐赠活动中可能会定植多药耐药菌。我们的筛查方案并没有导致多药耐药菌阳性的粪便悬液被批准用于菌群移植。
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