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Fecal microbiota transplantation: from practices to legislation before considering industrialization.
Clin Microbiol Infect. 2014 Oct 1;
Authors: Lagier JC
Abstract
Clostridium difficile recurrent infections are an important medical concern. Evidence has been provided showing that fecal microbiota transplantation is a more efficient alternative treatment compared with antibiotics. Serious side effects are unusual, and acceptability is not an obstacle. Nevertheless, protocols are heterogeneous with respect to the selection of donors or the methodology used for the fecal transplantation. Regulations by both the Food and Drug Administration (FDA) or the French authorities consider stool samples to be a drug and suggest strict supervision in clinical trials. Donor screening by questionnaire or by blood and stool analysis, which is essential in eliminating pathogens or viruses before transplantation, is similar in different countries, with few exceptions. The traceability of the fecal transplant and long-term follow-up of the patients in clinical trials are issues that may be difficult in organizing. The use of frozen microbiota facilitates transplantation, and the nasogastric route seems to be at least as effective as other invasive methods and avoids the risk of anesthesia. Synthetic microbiota is an approach that selects a mixture of bacteria, thereby eliminating the risk of transmissible disease; however, this approach is not yet evidence based. The use of pills, which is currently being tested in clinical trials, will certainly be the starting point for the extensive use and wide industrialization of fecal microbiota transplantation. This article is protected by copyright. All rights reserved.
PMID: 25273480 [PubMed - as supplied by publisher]