Stool Banking for Fecal Microbiota Transplantation: Methods and Operations at a Large Stool Bank

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.

16S rRNA sequencing of samples from universal stool bank donors

Objectives Universal stool banks provide stool to physicians for use in treating recurrent Clostridioides difficile infection via fecal microbiota transplantation. Stool donors providing the material are rigorously screened for diseases and disorders with a potential microbiome etiology, and they are likely healthier than the controls in most microbiome datasets. 16S rRNA sequencing was performed on samples from a selection of stool donors at a large stool bank, OpenBiome, to characterize their gut microbial community and to compare samples across different timepoints and sequencing runs. Data description 16S rRNA sequencing was performed on 200 samples derived from 170 unique stool donations from 86 unique donors. Samples were sequenced on 11 different sequencing runs. We are making this data available because rigorously screened, likely very healthy stool donors may be useful for characterizing and understanding microbial community differences across different populations and will help shed light into the how the microbiome community promotes health and disease.

STRUCTURING A FECAL MICROBIOTA TRANSPLANTATION CENTER IN A UNIVERSITY HOSPITAL IN BRAZIL

ABSTRACT BACKGROUND: Fecal microbiota transplantation (FMT) is an important therapeutic option for recurrent or refractory Clostridioides difficile infection, being a safe and effective method. Initial results suggest that FMT also plays an important role in other conditions whose pathogenesis involves alteration of the intestinal microbiota. However, its systematized use is not widespread, especially in Brazil. In the last decade, multiple reports and several cases emerged using different protocols for FMT, without standardization of methods and with variable response rates. In Brazil, few isolated cases of FMT have been reported without the implantation of a Fecal Microbiota Transplantation Center (FMTC). OBJECTIVE: The main objective of this study is to describe the process of implanting a FMTC with a stool bank, in a Brazilian university hospital for treatment of recurrent and refractory C. difficile infection. METHODS: The center was structured within the criteria required by international organizations such as the Food and Drug Administration, the European Fecal Microbiota Transplant Group and in line with national epidemiological and regulatory aspects. RESULTS: A whole platform involved in structuring a transplant center with stool bank was established. The criteria for donor selection, processing and storage of samples, handling of recipients before and after the procedure, routes of administration, short and long-term follow-up of transplant patients were determined. Donor selection was conducted in three stages: pre-screening, clinical evaluation and laboratory screening. Most of the candidates were excluded in the first (75.4%) and second stage (72.7%). The main clinical exclusion criteria were: recent acute diarrhea, overweight (body mass index ≥25 kg/m2) and chronic gastrointestinal disorders. Four of the 134 candidates were selected after full screening, with a donor detection rate of 3%. CONCLUSION: The implantation of a transplant center, unprecedented in our country, allows the access of patients with recurrent or refractory C. difficile infection to innovative, safe treatment, with a high success rate and little available in Brazil. Proper selection of qualified donors is vital in the process of implementing a FMTC. The rigorous clinical evaluation of donors allowed the rational use of resources. A transplant center enables treatment on demand, on a larger scale, less personalized, with more security and traceability. This protocol provides subsidies for conducting FMT in emerging countries.

Low Carriage Rates of Multidrug-Resistant Organisms in Prospective Stool Donors in a Large Fecal Microbiota Transplantation (FMT) Stool Bank

Background: Fecal microbiota transplantation (FMT) has emerged as standard of care for Clostridioides difficile not responsive to antibiotic therapy. Rigorous screening of healthy donors is critical to patient safety. As part of routine donor evaluation for FMT, multidrug-resistant organism (MDRO) screening is performed to assess the presence of extended-spectrum β-lactamase–producing organisms (ESBLs), vancomycin-resistant enterococci (VRE), carbapenem-resistant Enterobacteriaceae (CRE), and methicillin-resistant Staphylococcus aureus (MRSA). Carriage rates of these organisms in a healthy, low-risk population are largely unknown. We report MDRO carriage rates among individuals screened for a stool donation program at a large-scale FMT stool bank. Methods: Individuals were screened at a nonprofit stool bank (OpenBiome, Cambridge, MA). Potential donors underwent in-person clinical assessment, including MDRO risk factors (eg, travel, occupation, healthcare exposure). If they met the clinical assessment criteria, laboratory testing, including MDROs, was performed. Once enrolled in the donor program, donors underwent repeated clinical and laboratory screening at 60-day intervals, with intermittent health checks throughout the donation period. Stool samples provided at 60-day intervals were screened for MDROs (ie, ESBL, CRE, VRE), and nasal swabs for MRSA were tested using culture-based methods. All stool samples tested for MDROs from prospective and enrolled donors were included. Results: Between February 2017 and July 2019, 247 individuals were screened for MDROs. Overall, 11 samples (0.04%) tested positive for ESBL, MRSA, or VRE. No CRE carriers were identified. Also, 2 individuals tested positive twice for ESBL, resulting in 13 of 1,688 (0.77%) positive screens. International travel in the previous 12 months was reported by 6 of 11 MDRO carriers. Occupations typically associated with MDROs were not observed in carriers. Most of the MDRO-positive donors were students; however, students make up the majority of the stool donor cohort. Conclusions: This study is the first to report background MDRO carriage rates in a population of otherwise healthy FMT stool donors. Although rare, MDROs were detected and should be part of standard guidelines for FMT donor screening. Most subjects testing positive for MDROs had defined risk factors associated with MDRO carriage, including international travel or exposure to healthcare environments. However, occupational exposure was not a factor associated with carriage in this study. Standardized donor screening guidelines for FMT are urgently needed to ensure that MDROs and risk factors for MDRO carriage are routinely screened for by all FMT providers. Stool banks present a unique public health opportunity to evaluate the background carriage rate of MDROs in healthy populations.Funding: NoneDisclosures: None

Stool banking for fecal microbiota transplantation: methods and operations at a large stool bank

Objectives: Fecal microbiota transplantation (FMT) is a recommended therapy for recurrent Clostridioides difficile infection and is being investigated as a potential therapy for dozens of microbiome-mediated indications. Stool banks centralize FMT donor screening and FMT material preparation with the goal of improving the safety, quality, convenience, and accessibility of FMT material. Although there are published consensuses on donor screening guidelines, there are few reports about the implementation of those guidelines in functioning stool banks. Methods: To 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. Results: In 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. Conclusions: Further knowledge sharing should help inform refinements of stool banking guidelines and best practices.

Mitigating the Impact of the COVID-19 Outbreak (Vol. 24, No. 7, Full Issue)

For the month of July 2020, APBN will explore implications the COVID-19outbreak will have on food security in the Asia Pacific Region. In the Columns dive into primary care in the healthcare system looking at the importance of networks and increasing productivity through digitization. Read more on the interview with Associate Professor Jeremy Lim, founder of Southeast Asia's first stool bank, AMILI as the team works towards generating an understanding of the Asian gut microbiome.