Faecal microbiota transplantation: a regulatory hurdle?

Verbeke, Frederick; Wynendaele, Evelien

doi:10.1186/s12876-017-0687-5

Cited by 36 publications

(40 citation statements)

References 68 publications

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“…FMT harmonized regulations are lacking and the current regulatory status ranges from non-existing to strictly regulated (22). For now, the US FDA had classi ed FMT as a live biotherapeutic drug that requires the submission of Investigational New Drug application for its therapeutic uses (23).…”

Section: Discussionmentioning

confidence: 99%

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Knowledge, Attitudes and Ethical and Social Perspectives Towards Fecal Microbiota Transplantation (FMT) Among Jordanian Health Care Providers

Al‐Bakri

Akour

Al-Delaimy

2020

Preprint

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Background: Fecal microbiota transplant (FMT) is a treatment modality that involves the introduction of stool from a healthy pre-screened donor into the gastrointestinal tract of a patient. It exerts its therapeutic effects by remodeling the gut microbiota and treating microbial dysbiosis-imbalance. FMT is not regulated in Jordan, and demarcating regulatory framework for FMT therapy in Jordan, an Islamic conservative country, might be faced with unique cultural, social, religious and ethical challenges. The aim is to assess knowledge, attitudes and perceptions of ethical and social issues of FMT among Jordanian healthcare professionals.Methods: An observational, cross-sectional study design was used to assess knowledge, attitudes and perceptions of ethical and social issues of FMT among 300 Jordanian healthcare professionals. Results: A large proportion (39%) thought that the safety and efficacy of this technique is limited and 29.3% thought there is no evidence to support its use. Among the choices to select to use FMT, almost all (95%) would only perform it in certain cases, if ethically justified, and 48.3% would use it due to treatment failure. And for reasons not to use it, 40% would not perform it due to concerns about medical litigation, followed by fear of infections (38 %), and lack knowledge of long safety and efficacy (31.3 %). Interestingly, all practitioners would perform this procedure through the lower gastrointestinal tract modality and the majority will protect patient’s confidentiality via double-blinding (43.3%). For a subset of participants (n=100), the cultural constrains that might affect the choice of performing FMT were to the donor's religion, and dietary intake and alcohol consumption.Conclusion: Our health care practitioners are reluctant to use the FMT modality due to religious and ethical reasons but would consider it if there was failure of other treatment and after taking into consideration many other social and ethical restrictions.

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Section: Discussionmentioning

confidence: 99%

“…All these challenges, make it very di cult to demarcate the regulatory framework (23). Indeed, the regulatory status of FMT has been changed several times and is continuously modi ed [21,22].…”

Section: Introductionmentioning

confidence: 99%

Knowledge, Attitudes and Ethical and Social Perspectives Towards Fecal Microbiota Transplantation (FMT) Among Jordanian Health Care Providers

Al‐Bakri

Akour

Al-Delaimy

2020

Preprint

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“…Another new task is to regulate effectively all the diverse upcoming approaches in microbiome intervention (Aagaard and Hohmann, 2019). Many recommendations were issued regarding interventional approaches including probiotics with potential risks (Cohen, 2018) and FMT (Hoffmann et al, 2017;Verbeke et al, 2017), as well as novel food products targeting microbiome and aiming at microbiome health (Green et al, 2017).…”

Section: Fact 7: Self-purification and Discipline Mechanisms Exist Inmentioning

confidence: 99%

Seven facts and five initiatives for gut microbiome research

Gao

Zhang

et al. 2020

Protein Cell

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“…With an estimated 700,000 cases of CD infection annually in Europe and the United States, FMT is an emerging therapy with the potential to become routine practice. Fulfilling a demand of this scale requires an extensive and robust infrastructure.…”

Section: Perspectivementioning

confidence: 99%

Banking feces: a new frontier for public blood banks?

et al. 2019

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Fecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridioides difficile infection and is potentially beneficial in other microbiota-related disorders. The provision of FMT in routine clinical practice requires an extensive infrastructure that is reliant on voluntary donors. Alongside an increasing demand for FMT, the logistic barriers of a large-scale donor-dependent operation and the difficulties among health authorities to regulate FMT limit the dissemination of sustainable FMT services. Blood centers are large organizations that handle a multitude of donordependent operations on a daily basis. Blood and feces share many of the same dependencies, and feces may present a new opportunity for the blood services to handle. In this paper, we describe how an FMT service may be established and embedded within the blood service infrastructure, and we explain the benefits of using blood donors as feces donors. We further explore the current indications of FMT, the challenges related to the lack of legislation, and the future perspectives for blood banks to meet a new and increasing demand. ABBREVIATIONS: CD = Clostridioides difficile; EUTCD = European Tissue and Cells Directive; FMT = fecal microbiota transplantation; IND = investigational new drug; rCDI = recurrent Clostridioides difficile infection. From the

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Faecal microbiota transplantation: a regulatory hurdle?

Cited by 36 publications

References 68 publications

Knowledge, Attitudes and Ethical and Social Perspectives Towards Fecal Microbiota Transplantation (FMT) Among Jordanian Health Care Providers

Knowledge, Attitudes and Ethical and Social Perspectives Towards Fecal Microbiota Transplantation (FMT) Among Jordanian Health Care Providers

Seven facts and five initiatives for gut microbiome research

Banking feces: a new frontier for public blood banks?

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