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Background On June 13, 2019, the US Food and Drug Administration issued a warning after transfer of faeces containing an extended-spectrum beta-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.Methods 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.Findings 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.Interpretation 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. Copyright (C) 2020 Elsevier Ltd. All rights reserved.

Several experimental studies suggest a role of the gut microbiota in the pathophysiology of Parkinson’s disease (PD) via the gut-brain axis. In addition, the gut microbiota can influence the metabolism of levodopa, which is the mainstay of treatment of PD. Therefore, modifying the gut microbiota by fecal microbiota transplantation (FMT) could be a supportive treatment strategy. We developed a study protocol for a single center, prospective, self-controlled, interventional, safety and feasibility donor-FMT pilot study with randomization and double blinded allocation of donor feces. The primary objectives are to assess feasibility and safety of FMT in PD patients. Secondary objectives are to explore whether FMT leads to alterations of motor complications and PD symptoms in the short term, determine alterations in gut microbiota composition and donor-recipient microbiota similarities and their association with PD symptoms and motor complications, assess the ease of the study protocol and examine FMT-related adverse events in PD patients. The study population will consist of 16 idiopathic PD patients that use levodopa and experience motor complications. They will receive FMT with feces from one of two selected healthy human donors. Patients will be pretreated with vancomycin and bowel lavage to increase donor feces engraftment, and domperidone to prevent nausea and regurgitation. The FMT will be performed via direct injection of the fecal suspension into the duodenum via a gastroscope. There will be six follow-up moments during three months. Blood will be drawn on three occasions. Physical examination, filling in of questionnaires and a diary, and collection of stool samples are performed at baseline and each in-person follow-up visit (except for the FMT visit). This study was approved by the Medical Ethical Committee Leiden Den Haag Delft (ref. P20.087) and is registered in the Netherlands Trial Register (NL9438). Study results will be disseminated through publication in peer-reviewed journals and international conferences.