About: Regulation, risk and safety of Faecal Microbiota Transplant

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An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Regulation, risk and safety of Faecal Microbiota Transplant
Creator	Goldenberg, Simon Merrick, Blair Allen, Liz Forbes, Ben Masirah, Nur Shawcross, Debbie Zain, M Zain, Masirah
Source	Elsevier; PMC
abstract	Summary From its origins as a left-field, experimental, and even “maverick” intervention, faecal microbiota transplantation (FMT) is now a well-recognised, accepted, and potentially life-saving therapeutic strategy, for the management of recurrent Clostridiodes difficile infection (rCDI). It is being investigated as a treatment for a growing number of diseases including hepatic encephalopathy and eradication of antimicrobial resistant organisms, and the list of indications will likely expand in the future. There is no universally accepted definition of what FMT is, and its mechanism of action remains incompletely understood; this has likely contributed to the breadth of approaches to regulation depending on interpretation. In the UK FMT is considered a medicinal product, in North America, a biological product, whereas in parts of Europe, it is considered a human cell/ tissue product. Regulation seeks to improve quality and safety, however, lack of standardisation creates confusion, and overly restrictive regulation may hamper widespread access and discourage research using FMT. FMT is generally considered safe, especially if rigorous donor screening and testing is conducted. Most short-term risks are associated with the delivery method (e.g. colonoscopy). Longer term risks are less well described but longitudinal follow-up of treated cohorts is in place to assess for this, and no signal towards harm has been found to date. Rarely it has been associated with adverse outcomes including the transmission of antibiotic resistant bacteria, and even death. It is vital patients undergoing FMT are well informed to the currently appreciated risks and benefits before proceeding.
has issue date	2020-06-09(xsd:dateTime)
bibo:doi	10.1016/j.infpip.2020.100069
has license	els-covid
sha1sum (hex)	15bb5f9db827310b99c2fa3877d0065f66858811
schema:url	https://doi.org/10.1016/j.infpip.2020.100069
resource representing a document's title	Regulation, risk and safety of Faecal Microbiota Transplant
has PubMed Central identifier	PMC7280140
resource representing a document's body	covid:15bb5f9db827310b99c2fa3877d0065f66858811#body_text
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