Stool Bank Research Articles

Knowledge and perceptions of South African blood donors towards biobanking and stool donation.

The complexity of contexts and varied purposes for which biome donation are requested are unknown in South Africa. The aim of this study was to provide strategic data towards actualisation of whether a stool donor bank may be established as a collaborative between Western Cape Blood Services (WCBS) and the University of Cape Town (UCT). We designed a cross-sectional, questionnaire-based survey to determine willingness of WCBS blood donors to donate stool specimens for microbiome biobanking. The study was conducted between 01 June 2022 and 01 July 2022 at three WCBS donation centres in Cape Town, South Africa. Anonymous blood donors who met the inclusion criteria were enrolled. Anonymised demographic and interview data were analysed statistically. Analysis of responses from 209/231 blood donors demonstrated in a logistic regression model that compensation (p < 0.001) and 'societal benefit outweighs inconvenience' beliefs (p = 7.751e-05) were covariates significantly associated with willingness to donate stool. Age was borderline significant at a 5% level (p = 0.0556). Most willing stool donors indicated that donating stool samples would not affect blood donations (140/157, 90%). Factors decreasing willingness to donate were stool collection being unpleasant or embarrassing. The survey provides strategic data for the establishment of a stool bank and provided an understanding of the underlying determinants regarding becoming potential donors. This is the first report on the perspectives of potential participants in donating samples towards a stool microbiome biobank in South Africa, a necessity for faecal microbiota transplantation (FMT).

Evaluation of Bacterial Viability for Fecal Microbiota Transplantation: Impact of Thawing Temperature and Storage Time.

Fecal Microbiota Transplantation (FMT) represents a promising therapeutic tool under study for several purposes and is currently applied to the treatment of recurrent Clostridioides difficile infection. However, since the use of fresh stool was affected by several issues linked to donor screening, the development of a frozen stool bank is a reliable option to standardize FMT procedures. Nevertheless, different environmental factors impact microbial viability. Herein, we report the effect of different thawing temperatures and storage conditions on bacterial suspensions in the FMT procedure. In total, 20 stool samples were divided into aliquots and tested across a combination of different storing periods (15, 30; 90 days) and thawing procedures (4 °C overnight, room temperature for 1 h; 37 °C for 5 min). Focusing on storage time, our data showed a significant reduction in viability for aerobic and anaerobic bacteria after thawing for 15 days, while no further reductions were observed until after 90 days. Instead, among the different thawing procedures, no significant differences were observed for aerobic bacteria, while for anaerobes, thawing at 37 °C for 5 min was more effective in preserving the bacterial viability. In conclusion, the frozen fecal microbiota remained viable for at least three months, with an excellent recovery rate in all three thawing conditions.

A20 FECAL MICROBIOTA TRANSPLANTATION FORMULATIONS DO NOT AFFECT BACTERIAL VIABILITY OR TREATMENT OUTCOMES IN RECURRENT C. DIFFICILE INFECTION

Abstract Background Fecal microbiota transplantation (FMT) is the most effective therapy for recurrent Clostridioides difficile infections (rCDI) with multiple RCTs showing efficacy of 80-90%. Frozen FMT is a commonly used formulation but requires storage at -80°C, creating barriers to storage and transportation. More recently, lyophilized FMT (LFMT) has shown promise as an alternative formulation, but little data exists as to how bacterial viability may be affected compared to fresh or frozen FMT by different storage temperatures and duration, and real-world outcome data is sparse. As such, this study aims to evaluate the viability and efficacy of LFMT compared to fresh and frozen FMT. Aims To 1) compare bacterial viability in 3 FMT formulations: fresh, frozen and lyophilization, at varying storage temperatures and duration, and 2) correlate different formulations with treatment outcomes. Methods We compared bacterial viability using flow cytometry to determine the proportion of live vs dead bacteria on fresh, frozen and lyophilized donor stool samples stored at different temperatures (-80°C for frozen, -80°C and +4°C for LFMT) and duration (up to 12 months). We then retrospectively examined treatment success rates in rCDI patients who received fresh, frozen or LFMT at the University of Alberta since inception of the FMT program in 2012. Success is defined as no recurrence of CDI 8 weeks after receiving a single FMT treatment. Results Compared to fresh FMT (20% live cells), the proportions of live cells in frozen formulation stored at -80°C and lyophilized formulations stored at -80°C and 4°C did not diminish over time for up to 12 months as shown in Figure 1. Between 2013-2022, outcome data was available in 503 rCDI patients with baseline characteristics and treatment outcomes shown in Table 1. A logistic regression analysis comparing LFMT to frozen FMT resulted in an odds ratio of 0.14, indicating that success rate of LFMT is 14% higher than frozen FMT. Conclusions Our study showed that LFMT stored at either -80°C or 4°C over 12 months did not result in diminished bacterial viability compared with frozen FMT. Furthermore, treatment success rate following LFMT in rCDI patients was not lower than with frozen FMT. This finding has implication for stool banks and FMT programs as LFMT can be stored and shipped at 4°C, facilitating use in outpatient settings. Table 1. Baseline characteristics and success rates of rCDI patients who received fresh, frozen or LFMT. Figure 1. Proportions of live cells in frozen FMT stored at -80°C, LFMT stored at -80°C and 4°C, at 1, 3, 6, 9 and 12 months. Funding Agencies None

Fecal microbiome composition and diversity of cryopreserved canine stool at different duration and storage conditions.

Fresh-frozen stool banks intended for humans with gastrointestinal and metabolic disorders have been recently established and there are ongoing efforts to establish the first veterinary fresh-frozen stool bank. Fresh frozen stored feces provide an advantage of increased availability and accessibility to high-quality optimal donor fecal material. The stability of frozen canine feces regarding fecal microbiome composition and diversity has not been reported in dogs, providing the basis for this study. We hypothesized that fecal microbial composition and diversity of healthy dogs would remain stable when stored at -20°C and -80°C for up to 12 months compared to baseline samples evaluated before freezing. Stool samples were collected from 20 apparently healthy dogs, manually homogenized, cryopreserved in 20% glycerol and aliquoted, frozen in liquid nitrogen and stored at -20°C or -80°C for 3, 6, 9, and 12 months. At baseline and after period of storage, aliquots were thawed and treated with propidium monoazide before fecal DNA extraction. Following long-read 16S-rRNA amplicon sequencing, bacterial community composition and diversity were compared among treatment groups. We demonstrated that fresh-frozen canine stools collected from 20 apparently healthy dogs could be stored for up to 12 months at -80°C with minimal change in microbial community composition and diversity and that storage at -80°C is superior to storage at -20°C. We also found that differences between dogs had the largest effect on community composition and diversity. Relative abundances of certain bacterial taxa, including those known to be short-chain fatty acid producers, varied significantly with specific storage temperatures and duration. Further work is required to ascertain whether fecal donor material that differs in bacterial community composition and diversity across storage conditions and duration could lead to differences in clinical efficacy for specific clinical indications of fecal microbiota transplantation.

711. High Prevalence of Positive Cell Cytotoxicity Neutralization Assay in Symptomatic and Asymptomatic Pediatric Oncologic Patients

Abstract Background Clostridium difficile infection (CDI) is the most common cause of nosocomial diarrhea in the United States. This burden is more prevalent and severe in the oncologic population and is associated with greater morbidity and mortality. Diagnostic modalities are limited, and misdiagnosis is high with resultant mismanaged care – inappropriate antibiotics, and potentially missed opportunities for appropriate targeted care towards graft-versus-host disease or other etiologies. To date, no large-scale evaluations have been performed to characterize the incidence of true disease in this population or to help delineate predictive markers for true infections (cell cytotoxicity neutralization assay (CCNA) positivity). Methods This is a multi-center, prospective stool banking study from January 2020 to date enrolling pediatric patients with an oncologic diagnosis admitted at Advocate Children’s Hospital and Comer Children’s Hospital. Stool was collected weekly along with relevant clinical histories and symptomology. Isolates of C. difficile were cultured and CCNA performed. Stool was also collected during episodes of PCR diagnosed CDI. Results 65 unique subjects were enrolled over 183 admissions. 11 samples from 10 patients were thought to represent CDI with PCR positivity noted. Five of these specimens were confirmed as CCNA positive while the remainder did not have active toxin presence. Bristol type 4 stools or &amp;gt; 3 stools in 24 hours were significant factors for modeling CCNA positivity, but not for modeling PCR positivity. Notably 26 stool specimens were CCNA positive, and 21 did not have PCR tests done. Among all CCNA positive specimens, no significant difference was noted in symptomatology or antibiotic use. Conclusion Differentiating true CDI can be challenging. However, even in patients with high risk of alternative GI pathology, the frequency of stooling and stool characteristics can be used. Although considered the gold standard for assessment of disease, CCNA positivity in this population was noted in patients who were not evaluated for disease by their primary providers. Underdiagnosis is possible, but potentially less likely given the absence of clinically significant differentiation in symptoms. Host factors predisposing to disease are likely present. Disclosures Larry K. Kociolek, MD, MSCI, Merck: Grant/Research Support

Screening costs associated with donor selection for fecal microbiota transplantation for treatment of PD-1 refractory melanoma patients.

The gut microbiome acts as a tumor-extrinsic regulator of responses to immune-checkpoint inhibitors (ICIs) targeting PD-1 and CTLA-4 receptors. Primary resistance to anti-PD-1 ICI can be reversed via responder-derived fecal microbiota transplant (FMT) in patients with refractory melanoma. Efforts to create stool banks for FMT have proved difficult. Therefore, we aimed to establish a novel donor-screening program to generate responder-derived FMT for use in PD-1 refractory melanoma. Candidate PD-1 responder donors and PD-1 refractory recipients were recruited via clinic-based encounters at the University of Pittsburgh Medical Center hospitals. Eligible donors and recipients underwent physician assessment and screening of serum, stool and nasopharynx for transmissible agents, which included SARS-CoV-2 modification. The cost of donor and recipient screening was calculated. Initially, 29 donors were screened with 14 eligible donors identified after exclusion; of the 14 donors, eight were utilized in clinical trials. The overall efficiency of screening was 48%. Seroprevalence rates for cytomegalovirus, Epstein-Barr virus, HSV-2, HHV-6, HTLV-1, HTLV-2, and syphilis were similar to published statistics from healthy blood donors in the USA. Donor stool studies indicated a 3.6% incidence of E. histolytica and norovirus, 3.7% incidence of giardia and 7.1% incidence of C. difficile. A single donor tested positive for SARS-CoV-2 in stool only. The cost for finding a single eligible donor was $2260.24 (pre-COVID) and $2,460.24 (post-COVID). The observed screening efficiency suggests that a well-resourced screening program can generate sufficient responder-derived donor material for clinical trial purposes. Eliminating testing for low-prevalence organisms may improve cost-effectiveness.

Fecal microbiota transplantation in non-communicable diseases: Recent advances and protocols.

Fecal microbiota transplant (FMT) is a therapeutic method that aims to restore normal gut microbial composition in recipients. Currently, FMT is approved in the USA to treat recurrent and refractory Clostridioides difficile infection and has been shown to have great efficacy. As such, significant research has been directed toward understanding the potential role of FMT in other conditions associated with gut microbiota dysbiosis such as obesity, type 2 diabetes mellitus, metabolic syndrome, neuropsychiatric disorders, inflammatory bowel disease, irritable bowel syndrome, decompensated cirrhosis, cancers and graft-versus-host disease. This review examines current updates and efficacy of FMT in treating conditions other than Clostridioides difficile infection. Further, protocols for administration of FMT are also discussed including storage of fecal samples in stool banks, inclusion/exclusion criteria for donors, fecal sample preparation and methods of treatment administration. Overall, understanding the mechanisms by which FMT can manipulate gut microbiota to provide therapeutic benefit as well as identifying potential adverse effects is an important step in clarifying its long-term safety and efficacy in treating multiple conditions in the future.

Minimising the risk of monkeypox virus transmission during faecal microbiota transplantation: recommendations from a European expert panel

Faecal microbiota transplantation (FMT) is an established treatment for recurrent Clostridioides difficile infection, recommended by several guidelines for this indication.1,2 FMT is not only more effective than antibiotics for recurrent C difficile infection,3 but also able to prevent C difficile infection-related complications.4 Several actions have been taken to guarantee and expand FMT availability, and to increase its safety. Stool banks are a model that ensures a high level of product quality and reliability of supply.

Rejuvenating the human gut microbiome.

Industrial advances have caused significant loss of diversity in our gut microbiome, potentially increasing our susceptibility to many diseases. Recently, rewilding the human gut microbiome - that is, bringing it back to an ancestral or preindustrial state (e.g., by transplanting stool material from donors in nonindustrial societies) - has been hotly debated from medical, ethical, and evolutionary perspectives. Here we propose an alternative solution: rejuvenating the human gut microbiome by stool banking and autologous fecal microbiota transplantation, that is, collecting the hosts' stool samples at a younger age when they are at optimal health, and cryopreserving the samples in a stool bank for the hosts' own future use. In this article we discuss the motivation, applications, feasibility, and challenges of this solution.

Washed preparation of faecal microbiota changes the transplantation related safety, quantitative method and delivery.

SummaryThe safety, quantitative method and delivery of faecal microbiota transplantation (FMT) vary a lot from different countries in practice. Recently, the improved methodology of FMT based on the automatic filtration, washing process and the related delivery was named as washed microbiota transplantation (WMT). First, this study aimed to describe the methodology development of FMT from manual to washing preparation from 2012 to 2021 in China Microbiota Transplantation System (CMTS), a centralized stool bank for providing a national non‐profit service. The secondary aim is to describe donor screenings, the correlation between faecal weight and treatment doses, incidence of adverse events and delivery decision. The retrospective analysis on the prospectively recorded data was performed. Results showed that the success rate of donor screening was 3.1% (32/1036). The incidence rate of fever decreased significantly from 19.4% (6/31) in manual FMT to 2.7% (24/902) in WMT in patients with ulcerative colitis (UC), which made UC a considerable disease model to reflect the quality control of faecal microbiota preparation. We defined one treatment unit as 10 cm3 microbiota precipitation (1.0 × 1013 bacteria) based on enriched microbiota instead of rough faecal weight. For delivering microbiota, colonic transendoscopic enteral tube is a promising way especially for multiple WMTs or frequent colonic administration of drugs combined with WMT. This study should help improve the better practice of FMT for helping more patients in the future.

Effectiveness and Safety of Fecal Microbiota Transplantation for Clostridioides Difficile Infection: Results From a 5344-Patient Cohort Study

Effectiveness and Safety of Fecal Microbiota Transplantation for Clostridioides Difficile Infection: Results From a 5344-Patient Cohort Study

Draft Genome Sequences of a Bifidobacterium Strain and a Bacteroides Strain Isolated from a Human Stool Sample.

ABSTRACTWe present draft genome sequences of Bifidobacterium longum subsp. longum JCM 7050 and Bacteroides sp. strain 1_1_30 isolated from a healthy donor’s fecal sample obtained from a public stool bank, OpenBiome. Phylogenetic and functional analyses were performed to understand the physiological characteristics and functions of the strains in the human intestine.

Family Stool Donation Predicts Failure of Fecal Microbiota Transplant for Clostridioides difficile Infection.

Fecal microbiota transplant (FMT) via colonoscopy is highly effective treatment for Clostridioides difficile infection (CDI). We aimed to determine baseline patient characteristics that predict failure to respond to colonoscopy-based FMT. We evaluated adult patients who received FMT for CDI not responding to standard therapies at a single tertiary center between 2014 and 2018 in this retrospective cohort study. We defined clinical success as formed stool or C difficile-negative diarrhea at 2 months after FMT. If patients required a second FMT, follow-up was extended 2 months after repeat infusion. We performed multivariate logistic regression and a random forest model to identify variables predictive of response to FMT. Clinical success was attained in 87.3% of 103 patients who underwent FMT for CDI. In the multivariate model, the odds of FMT failure for family donation compared with stool bank were odds ratio 4.13 (1.00-7.01 P= .049). Diarrhea while taking anti-CDI antibiotics was common (37.8% of patients) and did not predict failure (odds ratio 0.64, 0.19-2.11 P= .46) in the univariate model. A machine learning model to predict response using clinical factors only achieved a sensitivity of 70%, specificity of 77%, and negative predictive value of 96%. Colonoscopy-based FMT was highly effective for CDI, even in a population where immunosuppression and proton pump inhibitor use were common. Family stool donation was associated with FMT failure, compared with the use of a stool bank. The study suggests that the use of a stool bank may not only improve access to FMT but also its efficacy.

A comprehensive approach to stool donor screening for faecal microbiota transplantation in China

BackgroundFaecal microbiota transplantation (FMT) is an effective therapy for recurrent Clostridium difficile infections and chronic gastrointestional infections. However, the risks of FMT and the selection process of suitable donors remain insufficiently characterized. The eligibility rate for screening, underlying microbial basis, and core ethical issues of stool donors for FMT are yet to be elucidated in China.ResultsThe potential stool donors were screened from December 2017 to December 2019 with the help of an online survey, clinical assessments, and stool and blood testing. Bioinformatics analyses were performed, and the composition and stability of gut microbiota in stool obtained from eligible donors were dynamically observed using metagenomics. Meanwhile, we build a donor microbial evaluation index (DoMEI) for stool donor screening. In the screening process, we also focused on ethical principles and requirements. Of the 2071 participants, 66 donors were selected via the screening process (3.19% success rate). Although there were significant differences in gut microbiota among donors, we found that the changes in the gut microbiota of the same donor were typically more stable than those between donors over time.ConclusionsDoMEI provides a potential reference index for regular stool donor re-evaluation. In this retrospective study, we summarised the donor recruitment and screening procedure ensuring the safety and tolerability for FMT in China. Based on the latest advances in this field, we carried out rigorous recommendation and method which can assist stool bank and clinicians to screen eligible stool donor for FMT.

Donor Screening for Fecal Microbiota Transplantation in China: Evaluation of 8483 Candidates

Donor Screening for Fecal Microbiota Transplantation in China: Evaluation of 8483 Candidates

Fecal Microbiota Transplantation in Patients With Recurrent Clostridium difficile Infection: A Four-Year Single-Center Retrospective Review.

BackgroundClostridium difficile infection (CDI) is a common cause of hospital and community-acquired diarrhea with an annual incidence of 453,000 cases in the USA. The white race, female gender, and age over 65 years are known risk factors. Recurrence of CDI is a major problem in patients taking antibiotics for prolonged periods. These patients are observed to have reduced diversity of the intestinal microbiome. Fecal microbiota transplantation (FMT) can restore the healthy flora in the gut, thus breaking the cycle of recurrent infection. Our study aimed to analyze the efficacy of FMT and the recurrence of CDI after FMT. We also aimed to investigate the effects of comorbidities on the outcome of FMT.MethodsAfter obtaining approval from the institutional review board, we included 64 patients who had received FMT at our institution from October 2015 to November 2019. All the patients over 16 years of age in both inpatient and outpatient settings were included. Patients under 16 years of age and patients treated without FMT were excluded. Frozen stool from a standardized stool bank (OpenBiome) was used. The thawed specimen was instilled into the terminal ileum or the cecum. Patients were followed up for the next 1 year for analysis of improvement in symptoms, recurrence, and repeat FMT.ResultsOn the 2-months follow-up, 75% of patients reported symptomatic improvement, 15.6% reported no improvement while 9.4% did not follow up. Twenty-six (40.6%) patients had CDI recurrence in the following year; and 69.2% of patients with recurrence underwent a repeat FMT. There was no statistically significant correlation between CDI recurrence and the age (P value = 0.68), gender (P value = 0.61), previous use of proton pump inhibitors (PPIs, P value = 0.11) or antibiotics (P value = 0.45). There was a statistically significant correlation noted with the use of immunosuppressants and recurrence (P value = 0.04).ConclusionsFMT is a successful treatment modality for refractory and recurrent CDI. Repeat treatments can be beneficial if there is a lack of initial response. Being immunosuppressed with medications is associated with the risk of recurrence.

The use of Faecal Microbiota Transplantation (FMT) in Europe: A Europe-wide survey.

BackgroundFaecal microbiota transplantation (FMT) is an emerging treatment modality, but its current clinical use and organisation are unknown. We aimed to describe the clinical use, conduct, and potential for FMT in Europe.MethodsWe invited all hospital-based FMT centres within the European Council member states to answer a web-based questionnaire covering their clinical activities, organisation, and regulation of FMT in 2019. Responders were identified from trials registered at clinicaltrials.gov and from the United European Gastroenterology (UEG) working group for stool banking and FMT.FindingsIn 2019, 31 FMT centres from 17 countries reported a total of 1,874 (median 25, quartile 10–64) FMT procedures; 1,077 (57%) with Clostridioides difficile infection (CDI) as indication, 791 (42%) with experimental indications, and 6 (0•3%) unaccounted for. Adjusted to population size, 0•257 per 100,000 population received FMT for CDI and 0•189 per 100,000 population for experimental indications. With estimated 12,400 (6,100–28,500) annual cases of multiple, recurrent CDI and indication for FMT in Europe, the current European FMT activity covers approximately 10% of the patients with indication. The participating centres demonstrated high safety standards and adherence to international consensus guidelines. Formal or informal regulation from health authorities was present at 21 (68%) centres.InterpretationFMT is a widespread routine treatment for multiple, recurrent CDI and an experimental treatment. Embedded within hospital settings, FMT centres operate with high standards across Europe to provide safe FMT. A significant gap in FMT coverage suggests the need to raise clinical awareness and increase the FMT activity in Europe by at least 10-fold to meet the true, indicated need.FundingNordForsk under the Nordic Council and Innovation Fund Denmark (j.no. 8056–00006B).

Stool Banking During the COVID-19 Pandemic: Experiences and a Retrospective Comparative Cohort Study

Background: Faecal microbiota transplantation (FMT) is an efficacious treatment for recurrent Clostridioides difficile infections (rCDI), and seems promising for other microbiota related disorders. Stool banks ensure safe and effective application of FMT by providing screened faecal suspensions from healthy donors. Due to the ongoing coronavirus disease 2019 (COVID-19) pandemic and the potential risk of SARS coronavirus-2 (SARS-CoV-2) transmission via FMT, many stool banks were forced to halt donor activities. Here we describe a strategy to effectively restart stool banking activities during the COVID-19 pandemic.Methods: We implemented periodic SARS-CoV-2 screening in donor faeces and serum, and frequent donor assessment for COVID-19 related symptoms. In this retrospective comparative cohort study, FMT donor and recipient data obtained before (2016-2019) and during the COVID-19 pandemic (March 2020-March 2021) was compared to assess stool banking efficacy.Findings: One active donor developed COVID-19 (10%, 1/10). Of 31 FMT-treated patients, one developed COVID-19 three weeks after FMT. No differences during versus before the COVID-19 pandemic were observed in the number of faecal donations (16 vs 22/month [-13·24-2·26], p=0·1); FMT requests for rCDI (3·8 vs 4·5/month [-2·22-0·83], p=0·3); rCDI patients eligible for FMT (73·8% vs 73·3%, OR=1·03 [0·48-2·21], p=0·9); rCDI cure rate (95·2% vs 89·1%, OR=0·41 [0·05-3·32], p=0·5); CDI free survival (p=0·1); the number of non-rCDI patients treated with FMT (five vs five), and the number of possibly FMT related adverse events (AEs) (12·0% vs 7·8%, OR=1·61 [0·40-6·42], p=0·7). Two FMTs for rCDI were delayed due to COVID-19. Clinical trials were hampered, however two out of three resumed all activities.Interpretation: There is a continued need for FMT treatment of rCDI. By implementing appropriate donor screening and SARS-CoV-2 infection prevention measures, safe, effective and efficient stool banking to facilitate FMT during the COVID-19 pandemic is possible.Funding Information: The Netherlands Donor Feces Bank has received an unrestricted grant of Vedanta Biosciences.Declaration of Interests: We declare no competing interests.Ethics Approval Statement: This study conforms to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in a priori approval by the institution’s Human Research Committee, and was approved on December 16th 2015 by the METC of the LUMC (P15.154). Written informed consent was provided by donors and patients for collection and analysis of clinical data and faeces samples.

Donor program for fecal microbiota transplantation: A 3-year experience of a large-volume Italian stool bank

BackgroundDue to the increasing rise of C. difficile infection, stool banks and donor programs have been launched to grant access to fecal microbiota transplantation (FMT). Our aim is to describe characteristics and outcomes of the donor program at our stool bank. MethodsDonor candidates underwent a four-step selection process, including a clinical interview, blood and stool testing, a further questionnaire and a direct stool testing the day of each donation. From March 2020, specific changes to this process were introduced to avoid the potential transmission of COVID-19. We evaluated the rate of excluded candidates at each step of the screening, as well as the number of total fecal aliquots provided by qualified donors. ResultsOverall, 114 donor candidates were evaluated. Seventy-five candidates declined to join the program for logistic or personal issues, three were excluded after the questionnaire and seven for positive stool exams. Finally, 29 (25%) subjects qualified as stool donors, and provided 70 stool samples. Fifteen samples were excluded after direct molecular stool testing. A total of 127 aliquots was finally obtained. ConclusionsDonor recruitment for FMT is a challenging process, and only a small rate of candidates are eligible as donors.

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.