Understanding the Scope of Do-It-Yourself (DIY) Fecal Microbiota Transplant (FMT)

Ekekezie, Chiazotam; Simmons, Shannon; Perler, Bryce K.; Burhke, Tamela; Duff, Catherine; Hott, Beth; Lillis, Christian John; Kelly, Colleen R.

doi:10.14309/00000434-201810001-00180

Cited by 3 publications

(4 citation statements)

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“…Second, the donor stool may be processed into an FMT treatment in an uncontrolled, ad hoc workspace, like a physician’s office, increasing the risk of contamination. Barriers to prompt access to FMT have also 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 ).…”

Section: Introductionmentioning

confidence: 99%

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

Zaman

Ramakrishna

Olesen

2021

Front. Cell. Infect. Microbiol.

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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.

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Section: Introductionmentioning

confidence: 99%

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

Zaman

Ramakrishna

Olesen

2021

Front. Cell. Infect. Microbiol.

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“…7 DIY FMT has been used to treat a variety of health problems. 8 Despite proponents' enthusiasm, evidence for FMT's efficacy in treating particular medical conditions varies from some to none, is not uniformly high-quality, does not explain how or why the intervention works (if it works), and leaves many unanswered questions about the conditions under which FMT is safe and effective. 9 Because stool is widely and cheaply available, healthcare providers and patients have had access to FMT in advance of strong evidence supporting its use.…”

Section: S Ince Data Began Accumulating From the Unitedmentioning

confidence: 99%

FMT and Microbial Medical Products: Generating High-Quality Evidence through Good Governance

Ossorio¹,

Zhou²

2019

J. Law. Med. Ethics

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This article argues that current data for the safety and efficacy of fecal microbiota transplants as a treatment for any indication, including recurrent Clostridioides difficile infection, is low-quality. It develops a governance proposal that encourages production of high-quality evidence by incentivizing well-designed RCTs of stool and stoolderived microbial products. The proposal would require that FDA change its current enforcement approach, but it would not require any change in statutes or regulations.

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“…Barriers to prompt access to FMT have also been reported as reasons for patients to seek "do-it-yourself" (DIY) FMT, which comes with significant risk to patient safety. 29 Stool banks address many of the logistical limitations inherent to the patient-selected donor model. A stool bank is a centralized facility that screens donors, processes stool, stores FMT preparations, fulfills clinicians' and researchers' requests for those preparations, and monitors the safety and efficacy of the material.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Zaman

Ramakrishna

Team

et al. 2020

Preprint

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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.

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Understanding the Scope of Do-It-Yourself (DIY) Fecal Microbiota Transplant (FMT)

Cited by 3 publications

References 0 publications

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

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

FMT and Microbial Medical Products: Generating High-Quality Evidence through Good Governance

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

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