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Universal Stool Donor Model for FMT Improves Screening, Reduces Costs, Delays
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Study data show the need for evidence-based stool screening standards, and the usefulness of the universal donor model for fecal microbiota transplantation (FMT) therapy for recurrent Clostridium difficile infection, according to a distinguished abstract presented at Digestive Disease Week.
“Where do we find these supremely healthy donors, and how do we know who is eligible to be a fecal transplant donor?” Laura J. Burns, from OpenBiome, an international public stool bank in Medford, Massachusetts, said in her presentation. “We have a three-step approach to recruiting and determining the eligibility of our donors.”
Aiming to elucidate the donor approval pathway, systematically identify eligible donors and determine criteria for donor exclusion, Burns and colleagues enrolled 459 individuals in their stool donor registry. As part of registry enrollment, prospective donors answered a pre-screening eligibility survey, which 55% passed. Of those who passed, 77 participants were selected to complete an onsite clinical assessment, which 35% passed. The twenty-seven individuals who passed the clinical assessment then underwent a comprehensive stool and serologic screening panel, and 44% passed, for a final enrollment of 12. The overall enrollment success rate was 8.5%; however, with updated data from 6,157 prospective donors, the overall pass rate dropped to 4.1%.
At each stage, prospective donors were eliminated for a number of reasons; findings from the clinical assessment that most frequently warranted exclusion were high-risk sexual behavior, psychiatric conditions and autoimmune diseases. Among the participants who underwent stool screening, the most common cause of failure was detection of asymptomatic rotavirus (n = 6) with no risk factors. Among the participants who underwent serum screening (n = 12), 100% passed.
“The current goal is to reach consensus guidelines, to determine how the field can best provide the safest FMT material today,” Burns said. “Furthermore, we want to encourage catalytic research into the investigation of not only efficacy but also safety of FMT. Ultimately, the gold standard is to facilitate evidence-based guidelines for finding safe donors.” – by Adam Leitenberger
Reference:
Burns L, et al. Abstract 499. Presented at: Digestive Disease Week, May 16-19, 2015; Washington, D.C.
Disclosure: Burns reports no relevant financial disclosures. Please see the DDW faculty disclosure index for all other researchers’ relevant financial disclosures.
Perspective
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Daniel A. Leffler, MD, MS
Fecal microbial transplantation is an excellent therapy for recurrent C. difficile infection, and what’s really keeping it from being used routinely across the country are the practical aspects of it. For the individual clinician — or even institutions — it is a difficult process. It’s not an off-the-shelf technique just yet, and what OpenBiome is doing is really providing the tools to make this a technique that clinicians can actually use more widely. The steps of turning this therapy from a cottage industry into something that is more reliable and user-friendly are very important.
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