Extended Screening Costs Associated With Selecting Donors for Fecal Microbiota Transplantation for Treatment of Metabolic Syndrome-Associated Diseases

Abstract

BackgroundKnowledge of the impact of the gut microbiome on conditions other than Clostridium difficile infection has been rapidly increasing, and the potential usefulness of fecal microbiota transplantation (FMT) in these indications is being explored. The need to exclude donors with an increased risk of these diseases has left uncertainties regarding the cost and feasibility of donor screening. The aim of this study was to compare our experience to other donor-screening programs and report the costs associated with establishing a donor-screening program, for the treatment of metabolic syndrome-related conditions.MethodsForty-six potential donors (PDs) had their medical histories and physical examinations undertaken by a physician. Blood, stool, and urine were screened for 31 viral, bacterial, fungal, and protozoan agents in addition to biochemical characteristics. The price of advertising, doctor’s visits and diagnostic tests were calculated to determine the cost of finding a donor.ResultsOf the PDs screened, 5 of 46 passed the history, examination, blood, stool, and urine tests. The most common reasons for exclusion included a body mass index >25 or the detection of Blastocystis hominis, Dientamoeba fragilis, or Helicobacter pylori. Four of five eligible donors had subsequent travel or illness that contraindicated donation, so only 1 of 46 PDs was suitable. The total cost for finding a single suitable donor was $15190 US dollars. This screening was performed in Canada, and costs in the United States would be substantially higher.ConclusionsNew potential therapeutic uses for FMT have created a demand for stricter exclusion criteria for donors. This study illustrates that screening many individuals to find a donor and the subsequent associated costs may make central processing and shipment a more reasonable alternative.

International consensus conference on stool banking for faecal microbiota transplantation in clinical practice

“…Observational data from a large stool bank suggest a high-rate of drop out and health-related exclusion from initial contact to stool donor qualification 42. Others small academic stool banks from Australia, Canada, USA and Denmark have reported similar challenges in procuring healthy donors 28 44–47. Accordingly, we recommend dedicated donor operational personnel who use a structured workflow to ensure access to material.…”

Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice

“…The parasites Dientamoeba fragilis and Blastocystis hominis in stools have been linked to gastrointestinal symptoms and their presence has been a common cause of donor exclusion in FMT studies 74. The pathogenicity of these organisms, however, has never been established in humans, and some studies suggest they may in fact be associated with health 75–83.…”

Fecal Transplant: How an Ancient Therapy Is Finding a New Use in Today’s Antibiotic-Resistant Era

“…Prior to this guidance, one review published in 2017 suggested screening for ESBL, but several others did not. [21][22][23] Owing to discrepancies in recommendations, clinical trials had not adopted ESBL as a standard screening metric for donor exclusion criteria, nor had many stool banks. [24][25][26] The guidance provided was a step in the right direction.…”

“…30 However, this timeline is rarely supported by evidence and varies widely in the literature from 3 to 6 months, even though research shows that antimicrobial exposure can have impacts lasting longer than 6 months. 22,26,31,32 Age has also been indicated as an important factor to consider. A suggested age range for donors is often between 18 and 50 years old.…”