Fecal transplant policy and legislation

作     者：Dinesh Vyas Apoorva Aekka Arpita Vyas 

作者机构：College of Human MedicineMichigan State UniversityEast LansingMI 48912United States Department of PediatricsHeart Failure Research LabEast LansingMI 48912United States 

出 版 物：《World Journal of Gastroenterology》 (世界胃肠病学杂志（英文版）)

年 卷 期：2015年第21卷第1期

页      面：6-11页

核心收录：

学科分类：1002[医学-临床医学] 100210[医学-外科学(含：普外、骨外、泌尿外、胸心外、神外、整形、烧伤、野战外)] 10[医学] 

主　　题：Stool therapy Clostridium difficile Fecal microbio 

摘      要：Fecal microbiota transplantation(FMT) has garnered significant attention in recent years in the face of a reemerging Clostridium difficile(***) *** results from the first randomized control trial evaluating FMT have encouraged the medical community to explore the process further and expand its application beyond *** infections and even the gastrointestinal *** promising and numerous the prospects of FMT appear,the method remains limited in scope today due to several important barriers,most notably a poorly defined federal regulatory *** Food and Drug Administrationhas found it difficult to standardize and regulate the administration of inherently variable,metabolically active,and ubiquitously available fecal *** current cumbersome policy,which classifies human feces as a drug,has prevented physicians from providing FMT and deserving patients from accessing FMT in a timely fashion,and subsequent modifications seem only to be *** argument for reclassifying fecal material as human tissue is well ***,this would allow for a regulatory framework that is sufficiently flexible to expand access to care and facilitate research,but also appropriately restrictive and centralized to ensure patient *** an approach can facilitate the advancement of FMT to a more refined,controlled,and aesthetic process,perhaps in the form of a customized and wellcharacterized stool substitute therapy.