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Prospective, Open-label Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Transplantation for Treatment of Recurrent C. difficile Infection
BACKGROUND: Fecal microbiota transplantation (FMT) has shown to be effective for recurrent Clostridium difficile infection (rCDI). However, significant laboratory costs for donor screening and a lack of suitable donors and laboratory facility have restricted the availability of the treatment. In ord...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5631555/ http://dx.doi.org/10.1093/ofid/ofx163.950 |
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author | Goldeh, Peyman Kim, Peter Abouanaser, Salaheddin Partlow, Eric Beckett, Patricia Onishi, Catherine Smieja, Marek Lee, Christine |
author_facet | Goldeh, Peyman Kim, Peter Abouanaser, Salaheddin Partlow, Eric Beckett, Patricia Onishi, Catherine Smieja, Marek Lee, Christine |
author_sort | Goldeh, Peyman |
collection | PubMed |
description | BACKGROUND: Fecal microbiota transplantation (FMT) has shown to be effective for recurrent Clostridium difficile infection (rCDI). However, significant laboratory costs for donor screening and a lack of suitable donors and laboratory facility have restricted the availability of the treatment. In order to expand access to FMT, we have investigated the efficacy of lyophilized FMT, comparing it to the published historical efficacy of frozen FMT in preventing further episodes of CDI in patients with a history of rCDI. This study was designed to be open-labeled to expedite and minimize costs associated with conducting a two-armed randomized controlled trial, given that the efficacy of frozen FMT is known to be 85%. Additionally, using lyophilized FMT offers two major advantages: 1) its prolonged shelf life reduces cost because fewer donors need to be screened; and 2) it can be transported without freezing. METHODS: This is an open-labeled, prospective study involving 50 patients with a history of 2 or more rCDI who have failed at least 1 course of tapered vancomycin therapy. Eligible patients received 2 lyophilized FMT via retention enema within 8 days of each treatment and were followed for 13 weeks post last FMT to determine efficacy and safety of FMT. RESULTS: The efficacy of lyophilized FMTs in preventing further episodes of CDI in patients with rCDI was 80%. The adverse events associated with lyophilized FMT were similar to frozen FMT. CONCLUSION: Lyophilized FMT in treating rCDI showed similar efficacy and safety to frozen FMT. Lyophilized FMT appears to be promising in preventing further episode of CDI and increasing accessibility for patients with rCDI. DISCLOSURES: All authors: No reported disclosures. |
format | Online Article Text |
id | pubmed-5631555 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-56315552017-11-07 Prospective, Open-label Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Transplantation for Treatment of Recurrent C. difficile Infection Goldeh, Peyman Kim, Peter Abouanaser, Salaheddin Partlow, Eric Beckett, Patricia Onishi, Catherine Smieja, Marek Lee, Christine Open Forum Infect Dis Abstracts BACKGROUND: Fecal microbiota transplantation (FMT) has shown to be effective for recurrent Clostridium difficile infection (rCDI). However, significant laboratory costs for donor screening and a lack of suitable donors and laboratory facility have restricted the availability of the treatment. In order to expand access to FMT, we have investigated the efficacy of lyophilized FMT, comparing it to the published historical efficacy of frozen FMT in preventing further episodes of CDI in patients with a history of rCDI. This study was designed to be open-labeled to expedite and minimize costs associated with conducting a two-armed randomized controlled trial, given that the efficacy of frozen FMT is known to be 85%. Additionally, using lyophilized FMT offers two major advantages: 1) its prolonged shelf life reduces cost because fewer donors need to be screened; and 2) it can be transported without freezing. METHODS: This is an open-labeled, prospective study involving 50 patients with a history of 2 or more rCDI who have failed at least 1 course of tapered vancomycin therapy. Eligible patients received 2 lyophilized FMT via retention enema within 8 days of each treatment and were followed for 13 weeks post last FMT to determine efficacy and safety of FMT. RESULTS: The efficacy of lyophilized FMTs in preventing further episodes of CDI in patients with rCDI was 80%. The adverse events associated with lyophilized FMT were similar to frozen FMT. CONCLUSION: Lyophilized FMT in treating rCDI showed similar efficacy and safety to frozen FMT. Lyophilized FMT appears to be promising in preventing further episode of CDI and increasing accessibility for patients with rCDI. DISCLOSURES: All authors: No reported disclosures. Oxford University Press 2017-10-04 /pmc/articles/PMC5631555/ http://dx.doi.org/10.1093/ofid/ofx163.950 Text en © The Author 2017. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Abstracts Goldeh, Peyman Kim, Peter Abouanaser, Salaheddin Partlow, Eric Beckett, Patricia Onishi, Catherine Smieja, Marek Lee, Christine Prospective, Open-label Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Transplantation for Treatment of Recurrent C. difficile Infection |
title | Prospective, Open-label Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Transplantation for Treatment of Recurrent C. difficile Infection |
title_full | Prospective, Open-label Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Transplantation for Treatment of Recurrent C. difficile Infection |
title_fullStr | Prospective, Open-label Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Transplantation for Treatment of Recurrent C. difficile Infection |
title_full_unstemmed | Prospective, Open-label Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Transplantation for Treatment of Recurrent C. difficile Infection |
title_short | Prospective, Open-label Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Transplantation for Treatment of Recurrent C. difficile Infection |
title_sort | prospective, open-label trial to evaluate efficacy of lyophilized fecal microbiota transplantation for treatment of recurrent c. difficile infection |
topic | Abstracts |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5631555/ http://dx.doi.org/10.1093/ofid/ofx163.950 |
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