Review of the Emerging Treatment of Clostridium difficile Infection with Fecal Microbiota Transplantation and Insights into Future Challenges

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Key points

  • Clostridium difficile infection (CDI) is one of the most common health care–associated infections in the United States, and there is concern regarding the emergence of community-acquired CDI.

  • Currently, there are no standardized methods to prepare or deliver the fecal microbiota transplantation (FMT). Various methods are used to prepare the FMT, which is usually administered via nasogastric tube, colonoscopy, or by enema.

  • Several clinical trials are underway to assess the true efficacy and safety

Fecal microbiota transplantation efficacy in Clostridium difficile

Despite the publication of an array of case reports and case series, until recently there has been a paucity of robust methodological studies evaluating FMT in CDI. Several systematic reviews have attempted to summarize the observational data, but there were intrinsic methodological limitations. These limitations were inclusion of unpublished data; an absence of an a priori minimum sample size threshold required to minimize the possibility of overestimating the treatment effect, given the

Fecal microbiota transplantation and its nexus with clinical guidelines

Given the scope of CDI and its multidisciplinary nature, evidence-based guidelines have been established by several organizations. These guidelines have included treatment approaches for recurrent CDI and more specific guidelines regarding FMT. The 2010 CDI clinical practice guidelines from the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America suggest vancomycin in a tapered and/or pulsed regimen for second CDI recurrence treatment (grade B-III). They

Technical review

Currently, there are no standardized methods to prepare or deliver the FMT. Various methods are used to prepare the FMT, which is usually administered via nasogastric tube, colonoscopy, or by enema.32, 35, 36, 43, 48, 49, 50 The best means to prepare, the ideal volume to use, and the optimal mode of delivery are yet to be defined. The following are important considerations before preparing the FMT. First, the transplant unit must ensure the availability of more than 1 reliable and fully

Future directions of fecal microbiota transplantation

Several clinical trials are underway to assess the true efficacy and safety of FMT for CDI. These trials include CDI studies assessing FMT via colonoscopy59 and frozen encapsulation,60 fresh versus frozen-and-thawed FMT by enema,61 FMT compared with a vancomycin taper,62 and FMT in the pediatric population.63 The results of these trials may shed light with regard to the best method to prepare and deliver FMT. In contrast to FMT whereby a complete microbial ecosystem is restored, there has been

Fecal microbiota transplantation: current regulatory landscape

In May 2013, the US Food and Drug Administration (FDA) delivered a public message that it would regulate human stool as a biological product and an investigational drug, in turn, requiring physicians to complete a laborious, 12- to 18-month investigational new drug (IND) application before performing FMT in any patient.29, 65 The FDA rationalized this requirement as a way to promote overall safer FMT, standardize therapy, and empower commercial development. At a public workshop jointly

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