Faecal microbiota transplantation in Australia: bogged down in regulatory uncertainty

Bryant, Robert V.

doi:10.1111/imj.14212

Cited by 12 publications

(8 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In 2014, the European Commission expressed an opinion that FMT is a ‘combined product’, given the presence of both human cells and non-human components (eg, microbial genes) within the material; however, given that the human cellular components of FMT are not generally believed to be the active components, they have decided that FMT falls outside of the European Tissues and Cells Directives, and have deferred regulation to different European countries for national/local regulation 33. The Therapeutic Goods Administration in Australia are currently formulating the regulatory framework for FMT in that country 34. The expert panel agreed that all stool banks should continue to operate under the designated regulatory authority for each country.…”

Section: Resultsmentioning

confidence: 99%

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

Cammarota

Ianiro

Kelly

et al. 2019

Gut

363

375

View full text Add to dashboard Cite

Although faecal microbiota transplantation (FMT) has a well-established role in the treatment of recurrent Clostridioides difficile infection (CDI), its widespread dissemination is limited by several obstacles, including lack of dedicated centres, difficulties with donor recruitment and complexities related to regulation and safety monitoring. Given the considerable burden of CDI on global healthcare systems, FMT should be widely available to most centres.Stool banks may guarantee reliable, timely and equitable access to FMT for patients and a traceable workflow that ensures safety and quality of procedures. In this consensus project, FMT experts from Europe, North America and Australia gathered and released statements on the following issues related to the stool banking: general principles, objectives and organisation of the stool bank; selection and screening of donors; collection, preparation and storage of faeces; services and clients; registries, monitoring of outcomes and ethical issues; and the evolving role of FMT in clinical practice,Consensus on each statement was achieved through a Delphi process and then in a plenary face-to-face meeting. For each key issue, the best available evidence was assessed, with the aim of providing guidance for the development of stool banks in order to promote accessibility to FMT in clinical practice.

show abstract

Section: Resultsmentioning

confidence: 99%

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

Cammarota

Ianiro

Kelly

et al. 2019

Gut

363

375

View full text Add to dashboard Cite

show abstract

“…Regulatory uncertainty continues to pose as a barrier for service delivery, and the development of a regulatory framework is essential for the efficient and safe delivery of this therapy. 12,36 This study had a number of limitations. First, a third of patients did not respond to the survey, and primary cure was more common in those who responded, which may overestimate the reports of satisfaction with treatment.…”

Section: Discussionmentioning

confidence: 98%

“…10 Local logistical and regulatory issues exist, which serve as barriers to widespread and equitable access to FMT for patients with rCDI. 12 In addition to this, physician and patient attitudes may also be barriers to the uptake of FMT, with limited awareness, provider resistance, and lack of availability cited as potential contributing factors. 13 With the establishment of a state-based stool bank in South Australia in 2013, 14,15 there has been universal access to this therapy within the public health system in the state.…”

Section: Introductionmentioning

confidence: 99%

Physician and patient perceptions of fecal microbiota transplant for recurrent or refractory Clostridioides difficile in the first 6 years of a central stool bank

et al. 2020

Self Cite

View full text Add to dashboard Cite

Background and Aim: Fecal microbiota transplantation (FMT) is a highly effective therapy for recurrent or refractory Clostridioides difficile infection (rCDI). Despite inclusion in society guidelines, the uptake of FMT therapy has been variable. Physician and patient attitudes may be a barrier to evidence-based uptake of therapies; however, data assessing attitudes regarding FMT for rCDI are limited. Methods: The South Australian FMT for CDI database prospectively recorded patient outcomes of FMT for CDI from August 2013 to January 2019. A total of 93 consecutive patients who underwent FMT for rCDI in South Australia were invited to participate in a 20-question survey regarding the patient experience of FMT. All gastroenterologists and infectious disease physicians practicing in South Australia were invited to participate in an online survey comprised of 22 questions that addressed referral experience, indications for referral, perceived risks, and regulation and funding. Results: Fifty-four patients (54/93, 58%) returned the survey, of whom 52 (96%) would recommend FMT to others, and 51 (94%) were satisfied with treatment outcome. Fifty physicians returned the online survey (50/100, 50%), of whom 23 (46%) were concerned about disease transmission risk, and 15 (30%) believed that the risk of FMT would outweigh the benefit. Infectious diseases physicians and advanced trainees had significantly greater concern regarding the potential alteration of the microbiome than gastroenterology physicians and advanced trainees (8/17 (47%) vs 6/ 33 (18%); P = 0.047). Conclusion: Despite high levels of patient-reported satisfaction following FMT, physician-reported reservations exist and may present a barrier to uptake of this therapy.

show abstract

“…Awareness of CDI and FMT prior to the study was established using two items, scored yes, no, unsure [32]. Following this, all participants read short paragraphs describing CDI [34][35][36], FMT [37][38][39], and typical requirements for donors and donation to ensure equivalency of knowledge before indicating willingness to donate (S2 Appendix). Willingness to donate to a stool bank was measured via one-item scales across scenarios that varied location: at a collection facility (in-centre) (unknown recipient), at home and deliver to a facility (unknown recipient); and purpose: for a loved one, research, or to develop new treatment(s).…”

Section: Methodsmentioning

confidence: 99%

Determinants of community members’ willingness to donate stool for faecal microbiota transplantation

Hyde

Masser

2020

PLoS ONE

View full text Add to dashboard Cite

Universal stool banks rely on, but face difficulties recruiting, community volunteers to donate stool for faecal microbiota transplantation (FMT) to effectively treat recurrent Clostridioides difficile. This study sought to identify determinants of community members’ willingness to donate stool to guide donor recruitment. 397 Australian residents (52% male, 47% 21–30 years, 63% university educated) completed a survey to gauge willingness to donate stool, bowel habits, information needs, attitudes, barriers, and motives for donation. Most reported regular bowel movements (BMs; 90%), morning BMs (63%), BMs ≤5 minutes duration (67%), and some discomfort doing BMs in public restrooms (69%). Less than half were willing to donate stool in-centre (45% willing) or at home (48%). Important information needs identified by >80% were convenience and travel requirements associated with donation. Main barriers were logistics, capabilities to donate, disgust (e.g., donation process), and discomfort (e.g., privacy). The main motivator was altruism, with compensation secondary. Linear regression models identified less discomfort doing BMs in public restrooms (β = -0.15), understanding benefits to patients (β = 0.15), placing less importance on understanding the donation process (β = -0.13), and positive attitudes (β = 0.56) as determinants of willingness to donate in-centre. Understanding benefits to self (β = 0.11) and patients (β = 0.24), placing less importance on understanding the donation purpose (β = -0.19), and positive attitudes (β = 0.50) determined willingness to donate at home. Stool banks should consider donor’s bowel habits, comfort donating in-centre, and information needs early in recruitment; and implement flexible logistics for potential donors who face time constraints and limited access to stool banks.

show abstract

Faecal microbiota transplantation in Australia: bogged down in regulatory uncertainty

Cited by 12 publications

References 21 publications

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

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

Physician and patient perceptions of fecal microbiota transplant for recurrent or refractory Clostridioides difficile in the first 6 years of a central stool bank

Determinants of community members’ willingness to donate stool for faecal microbiota transplantation

Contact Info

Product

Resources

About