Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Butler University, 4600 Sunset Ave, Indianapolis, Indiana, 46208, USA.
AAPS PharmSciTech. 2020 Apr 15;21(3):114. doi: 10.1208/s12249-020-1637-z.
The community of symbiotic microorganisms that reside in our gastrointestinal tract is integral to human health. Fecal microbiota transplantation (FMT) has been shown to be highly effective in treating recurrent Clostridioides difficile infection (rCDI) and is now recommended by medical societies for patients suffering from rCDI who have failed to respond to conventional therapy. The main challenges with FMT are its accessibility, acceptability, lack of standardization, and regulatory complexity, which will be discussed in this review. Access to FMT is being addressed through the development of frozen and lyophilized FMT preparations that can be prepared at stool banks and shipped to the point of care. Both access and patient acceptance would be enhanced by oral FMT capsules, and there is potential to reduce capsule burden by utilizing colonic release capsules, targeting the site of disease. This review compares the efficacy of different FMT routes of administration: capsules, nasal feeding tubes, enemas, and colonoscopic infusions. FMT is considered investigational by the Food and Drug Administration. In effort to improve access to FMT, physicians may perform FMT outside of an investigational new drug application for treating CDI infections not responsive to standard therapies. The majority of FMT studies report only minor adverse effects; however, there is risk of transmission of infections.
定植于胃肠道的共生微生物群落对人类健康至关重要。粪菌移植(FMT)已被证实对复发性艰难梭菌感染(rCDI)具有高度疗效,并且现在被医学协会推荐用于常规治疗失败的 rCDI 患者。FMT 的主要挑战在于其可及性、可接受性、缺乏标准化和监管复杂性,这些将在本综述中讨论。通过开发可在粪便库中制备并运送到护理点的冷冻和冻干 FMT 制剂,正在解决 FMT 的可及性问题。口服 FMT 胶囊可提高 FMT 的可及性和患者接受度,并且通过利用靶向疾病部位的结肠释放胶囊,可以减少胶囊负担。本综述比较了不同 FMT 给药途径的疗效:胶囊、鼻饲管、灌肠和结肠镜下输注。FMT 被食品和药物管理局认为是一种研究性药物。为了提高 FMT 的可及性,医生可能会在未进行新药临床试验的情况下,对标准治疗反应不佳的 CDI 感染患者进行 FMT。大多数 FMT 研究报告仅有轻微的不良反应,但存在感染传播的风险。