Alimentary Pharmacology and Therapeutics
Invited Editorials Editorial: a simple faecal preparation protocol for faecal microbiota transplantation C. R. Kelly Lifespan Women’s Medicine Collaborative, Warren Alpert Medical School of Brown University, Providence, RI, USA. E-mail: [email protected] doi:10.1111/apt.13039
Faecal microbiota transplantation (FMT) appears to be highly effective for the treatment of recurrent and refractory Clostridium difficile infection. Although assumed by many to be simple and low cost, there are a number of challenges around the process, related to identification and screening of individual donors. Others have described standardised preparations of faecal material which can be frozen and thawed for use,1, 2 with data from these previous publications indicating that the efficacy of highly processed preparations is comparable to that of fresh stool. In these studies, processing was typically carried out under anaerobic conditions, utilising commercial blenders, centrifuges and stainless steel sieves, and using laboratory space not widely available. In their paper, Satokari et al. describe a simple, low-cost method for preparing and storing donor stool.3 Their methods require minimal materials, laboratory space, equipment or technical expertise. Though they used a 80 °C freezer to store the material, storage in a standard medical freezer, available at any clinic, should not adversely affect viability of the microbiota. As in prior studies, the efficacy of FMT in this series did not appear to be compromised by the stool processing and storage. Furthermore, their methods appear to be cost effective, as once a donor has been screened, multiple treatment doses are obtained, and the preparations
described cost only a few dollars each. The authors administered FMT by colonoscopy, but administration by sigmoidoscopy could further reduce costs and procedural risk to patients. Frozen preparations of donor material will enable eligible patients to be treated more easily and will certainly facilitate clinical research. While FMT is becoming more widespread, it is important to remember that there has been only a single randomised, controlled trial published to date.4 While methods to increase the ease of the FMT process are exciting, we must also look towards larger, placebo-controlled studies, which are needed to confirm the efficacy and long-term safety of this therapy.
ACKNOWLEDGEMENT Declaration of personal interests: Colleen R. Kelly has received research funding from The National Institutes of Health (NIDDK) and Assembly Biosciences, INC. She is a clinical investigator for Seres Health. She serves as a volunteer member of the scientific advisory board for the AGA Center for Gut Microbiome Research and Education. Declaration of funding interests: None. REFERENCES 1. Hamilton MJ, Weingarden AR, Sadowsky MJ, et al. Standardized frozen preparation for transplantation of fecal microbiota for recurrent Clostridium difficile infection. Am J Gastroenterol 2012; 107: 761–7. 2. Youngster I, Sauk J, Pindar C, et al. Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study. Clin Infect Dis 2014; 58: 1515–22. 3. Satokari R, Mattila E, Kainulainen V, Arkkila PET. Simple faecal preparation and efficacy of frozen inoculum in faecal microbiota transplantation for recurrent Clostridium difficile infection – an observational cohort study. Aliment Pharmacol Ther 2015; 41: 46–53. 4. van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med 2013; 368: 407–15.
AP&T invited editorial columns are restricted to discussing papers that have been published in the journal. An editorial must have a maximum of 300 words, may contain one table or figure, and should have no more than 10 references. It should be submitted electronically to the Editors via http://mc.manuscriptcentral.com/apt.
320
ª 2015 John Wiley & Sons Ltd
Copyright of Alimentary Pharmacology & Therapeutics is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Invited Editorials Editorial: a simple faecal preparation protocol for faecal microbiota transplantation C. R. Kelly Lifespan Women’s Medicine Collaborative, Warren Alpert Medical School of Brown University, Providence, RI, USA. E-mail: [email protected] doi:10.1111/apt.13039
Faecal microbiota transplantation (FMT) appears to be highly effective for the treatment of recurrent and refractory Clostridium difficile infection. Although assumed by many to be simple and low cost, there are a number of challenges around the process, related to identification and screening of individual donors. Others have described standardised preparations of faecal material which can be frozen and thawed for use,1, 2 with data from these previous publications indicating that the efficacy of highly processed preparations is comparable to that of fresh stool. In these studies, processing was typically carried out under anaerobic conditions, utilising commercial blenders, centrifuges and stainless steel sieves, and using laboratory space not widely available. In their paper, Satokari et al. describe a simple, low-cost method for preparing and storing donor stool.3 Their methods require minimal materials, laboratory space, equipment or technical expertise. Though they used a 80 °C freezer to store the material, storage in a standard medical freezer, available at any clinic, should not adversely affect viability of the microbiota. As in prior studies, the efficacy of FMT in this series did not appear to be compromised by the stool processing and storage. Furthermore, their methods appear to be cost effective, as once a donor has been screened, multiple treatment doses are obtained, and the preparations
described cost only a few dollars each. The authors administered FMT by colonoscopy, but administration by sigmoidoscopy could further reduce costs and procedural risk to patients. Frozen preparations of donor material will enable eligible patients to be treated more easily and will certainly facilitate clinical research. While FMT is becoming more widespread, it is important to remember that there has been only a single randomised, controlled trial published to date.4 While methods to increase the ease of the FMT process are exciting, we must also look towards larger, placebo-controlled studies, which are needed to confirm the efficacy and long-term safety of this therapy.
ACKNOWLEDGEMENT Declaration of personal interests: Colleen R. Kelly has received research funding from The National Institutes of Health (NIDDK) and Assembly Biosciences, INC. She is a clinical investigator for Seres Health. She serves as a volunteer member of the scientific advisory board for the AGA Center for Gut Microbiome Research and Education. Declaration of funding interests: None. REFERENCES 1. Hamilton MJ, Weingarden AR, Sadowsky MJ, et al. Standardized frozen preparation for transplantation of fecal microbiota for recurrent Clostridium difficile infection. Am J Gastroenterol 2012; 107: 761–7. 2. Youngster I, Sauk J, Pindar C, et al. Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study. Clin Infect Dis 2014; 58: 1515–22. 3. Satokari R, Mattila E, Kainulainen V, Arkkila PET. Simple faecal preparation and efficacy of frozen inoculum in faecal microbiota transplantation for recurrent Clostridium difficile infection – an observational cohort study. Aliment Pharmacol Ther 2015; 41: 46–53. 4. van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med 2013; 368: 407–15.
AP&T invited editorial columns are restricted to discussing papers that have been published in the journal. An editorial must have a maximum of 300 words, may contain one table or figure, and should have no more than 10 references. It should be submitted electronically to the Editors via http://mc.manuscriptcentral.com/apt.
320
ª 2015 John Wiley & Sons Ltd
Copyright of Alimentary Pharmacology & Therapeutics is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
