Abstract
ObjectivesFecal microbiota transplantation (FMT) is a recommended therapy for recurrent Clostridioides difficile infection and is being investigated as a potential therapy for dozens of microbiota-mediated indications. Stool banks centralize FMT donor screening and FMT material preparation with the goal of expanding access to FMT material while simultaneously improving its safety, quality, and convenience. Although there are published consensuses on donor screening guidelines, there are few reports about the implementation of those guidelines in functioning stool banks.MethodsTo help inform consensus standards with data gathered from real-world settings and, in turn, to improve patient care, here we describe the general methodology used in 2018 by OpenBiome, a large stool bank, and its outputs in that year.ResultsIn 2018, the stool bank received 7,536 stool donations from 210 donors, a daily average of 20.6 donations, and processed 4,271 of those donations into FMT preparations. The median time a screened and enrolled stool donor actively donated stool was 5.8 months. The median time between the manufacture of an FMT preparation and its shipment to a hospital or physician was 8.9 months. Half of the stool bank’s partner hospitals and physicians ordered an average of 0.75 or fewer FMT preparations per month.ConclusionsFurther knowledge sharing should help inform refinements of stool banking guidelines and best practices.
Highlights
Fecal microbiota transplantation (FMT)’s reported safety profile and efficacy in preventing recurrence of C. difficile infection, approximately 80-90%, has inspired research using FMT to treat a wide range of microbiota-mediated indications (Allegretti et al, 2019a; Olesen et al, 2020)
Between March 2018 and July 2018, 731 candidate stool donors completed a survey asking for their motivations for donating stool
In 2018, the stool bank received 7,536 donations (Figure 4A) from 210 donors (Figure 4B), an average of 20.6 donations per day. 7% of donations (516/7,536) were used for stool screening purposes, to assess the donors’ health. 36% of donations (2,749/7,536) were rejected due to the donation’s low weight, poor Bristol stool score, visual stool pathology, or because the donation could not be processed within 6 hours of passage
Summary
Fecal microbiota transplantation (FMT), the transfer of minimally manipulated stool and its associated microbiota from a healthy donor into the gastrointestinal tract of the patient (Khoruts and Sadowsky, 2016; Allegretti et al, 2019a), is a recommended therapy for recurrent Clostridioides difficile infection (Surawicz et al, 2013; Debast et al, 2014; McDonald et al, 2018; Mullish et al, 2018; Davidovics et al, 2019). FMT’s reported safety profile and efficacy in preventing recurrence of C. difficile infection, approximately 80-90% (van Nood et al, 2013; Youngster et al, 2014a; Youngster et al, 2014b; Cammarota et al, 2015; Hirsch et al, 2015; Youngster et al, 2016; Allegretti et al, 2016; Kelly et al, 2016; Kao et al, 2017), has inspired research using FMT to treat a wide range of microbiota-mediated indications (Allegretti et al, 2019a; Olesen et al, 2020). The donor typically donates material for only that single patient This approach places substantial logistical burden on the physician (Bakken et al, 2013) and creates delays between the determination that FMT is indicated and the delivery of therapy. Barriers to prompt access to FMT have been reported as reasons for patients to seek “do-it-yourself” (DIY) FMT, which comes with significant risk to patient safety (Ekekezie et al, 2018)
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