Structuring a fecal microbiota transplantation center in a university hospital in Brazil

Detalhes bibliográficos
Autor(a) principal: Daniel Antônio de Albuquerque Terra
Data de Publicação: 2020
Outros Autores: Eduardo Garcia Vilela, Rodrigo Otávio Silveira Silva, Laiane Alves Leão, Karine Sampaio Lima, Raissa Iglesias Fernandes Ângelo Passos, Amanda Nadia Diniz, Luiz Gonzaga Vaz Coelho
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFMG
Texto Completo: https://doi.org/10.1590/S0004-2803.202000000-79
http://hdl.handle.net/1843/51785
https://orcid.org/0000-0001-9691-6512
https://orcid.org/0000-0002-5443-7553
https://orcid.org/0000-0003-0074-2488
https://orcid.org/0000-0001-6547-3798
https://orcid.org/0000-0001-8897-3410
https://orcid.org/0000-0003-0705-5568
https://orcid.org/0000-0002-5287-5779
https://orcid.org/0000-0002-8721-7696
Resumo: Background: Fecal microbiota transplantation (FMT) is an important therapeutic option for recurrent or refractory Clostridioides difficile infection, being a safe and effective method. Initial results suggest that FMT also plays an important role in other conditions whose pathogenesis involves alteration of the intestinal microbiota. However, its systematized use is not widespread, especially in Brazil. In the last decade, multiple reports and several cases emerged using different protocols for FMT, without standardization of methods and with variable response rates. In Brazil, few isolated cases of FMT have been reported without the implantation of a Fecal Microbiota Transplantation Center (FMTC). Objective: The main objective of this study is to describe the process of implanting a FMTC with a stool bank, in a Brazilian university hospital for treatment of recurrent and refractory C. difficile infection. Methods: The center was structured within the criteria required by international organizations such as the Food and Drug Administration, the European Fecal Microbiota Transplant Group and in line with national epidemiological and regulatory aspects. Results: A whole platform involved in structuring a transplant center with stool bank was established. The criteria for donor selection, processing and storage of samples, handling of recipients before and after the procedure, routes of administration, short and long-term follow-up of transplant patients were determined. Donor selection was conducted in three stages: pre-screening, clinical evaluation and laboratory screening. Most of the candidates were excluded in the first (75.4%) and second stage (72.7%). The main clinical exclusion criteria were: recent acute diarrhea, overweight (body mass index ≥25 kg/m2) and chronic gastrointestinal disorders. Four of the 134 candidates were selected after full screening, with a donor detection rate of 3%. Conclusion: The implantation of a transplant center, unprecedented in our country, allows the access of patients with recurrent or refractory C. difficile infection to innovative, safe treatment, with a high success rate and little available in Brazil. Proper selection of qualified donors is vital in the process of implementing a FMTC. The rigorous clinical evaluation of donors allowed the rational use of resources. A transplant center enables treatment on demand, on a larger scale, less personalized, with more security and traceability. This protocol provides subsidies for conducting FMT in emerging countries.
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spelling 2023-04-11T00:51:45Z2023-04-11T00:51:45Z2020574434458https://doi.org/10.1590/S0004-2803.202000000-791678-4219http://hdl.handle.net/1843/51785https://orcid.org/0000-0001-9691-6512https://orcid.org/0000-0002-5443-7553https://orcid.org/0000-0003-0074-2488https://orcid.org/0000-0001-6547-3798https://orcid.org/0000-0001-8897-3410https://orcid.org/0000-0003-0705-5568https://orcid.org/0000-0002-5287-5779https://orcid.org/0000-0002-8721-7696Background: Fecal microbiota transplantation (FMT) is an important therapeutic option for recurrent or refractory Clostridioides difficile infection, being a safe and effective method. Initial results suggest that FMT also plays an important role in other conditions whose pathogenesis involves alteration of the intestinal microbiota. However, its systematized use is not widespread, especially in Brazil. In the last decade, multiple reports and several cases emerged using different protocols for FMT, without standardization of methods and with variable response rates. In Brazil, few isolated cases of FMT have been reported without the implantation of a Fecal Microbiota Transplantation Center (FMTC). Objective: The main objective of this study is to describe the process of implanting a FMTC with a stool bank, in a Brazilian university hospital for treatment of recurrent and refractory C. difficile infection. Methods: The center was structured within the criteria required by international organizations such as the Food and Drug Administration, the European Fecal Microbiota Transplant Group and in line with national epidemiological and regulatory aspects. Results: A whole platform involved in structuring a transplant center with stool bank was established. The criteria for donor selection, processing and storage of samples, handling of recipients before and after the procedure, routes of administration, short and long-term follow-up of transplant patients were determined. Donor selection was conducted in three stages: pre-screening, clinical evaluation and laboratory screening. Most of the candidates were excluded in the first (75.4%) and second stage (72.7%). The main clinical exclusion criteria were: recent acute diarrhea, overweight (body mass index ≥25 kg/m2) and chronic gastrointestinal disorders. Four of the 134 candidates were selected after full screening, with a donor detection rate of 3%. Conclusion: The implantation of a transplant center, unprecedented in our country, allows the access of patients with recurrent or refractory C. difficile infection to innovative, safe treatment, with a high success rate and little available in Brazil. Proper selection of qualified donors is vital in the process of implementing a FMTC. The rigorous clinical evaluation of donors allowed the rational use of resources. A transplant center enables treatment on demand, on a larger scale, less personalized, with more security and traceability. This protocol provides subsidies for conducting FMT in emerging countries.Contexto: O Transplante de microbiota fecal (TMF) é uma importante opção terapêutica para a infecção recorrente ou refratária pelo Clostridioides difficile, sendo método seguro e eficaz. Resultados iniciais sugerem que o TMF também desempenha papel relevante em outras afecções cuja patogênese envolve a alteração da microbiota intestinal. No entanto, seu uso sistematizado é pouco difundido, especialmente no Brasil. Na última década, surgiram múltiplos relatos e séries de casos utilizando diferentes protocolos para o TMF, sem padronização de métodos e com taxas de resposta variáveis. No Brasil, poucos casos isolados de TMF foram relatados sem a implantação de um Centro de Transplante de Microbiota Fecal (CTMF). Objetivo: O principal objetivo deste estudo foi descrever o processo de implantação de um CTMF com banco de fezes, em hospital universitário brasileiro, para tratamento de infecção recorrente e refratária pelo C. difficile. Métodos: O CTMF foi estruturado dentro dos critérios exigidos e aprovados por organismos internacionais como o Food and Drug Administration, Grupo Europeu de Transplante de Microbiota Fecal e em consonância com os aspectos epidemiológicos e regulatórios nacionais. Resultados: Foi estabelecida toda uma plataforma envolvida na estruturação de um centro de transplante com fezes congeladas. Determinou-se os critérios para seleção de doadores, processamento e armazenamento de amostras, manejo dos receptores antes e após o procedimento, uniformização de vias de administração do substrato fecal e seguimento a curto e longo prazo dos pacientes transplantados. A seleção dos doadores foi conduzida em três etapas: pré-triagem, avaliação clínica e exames laboratoriais. Boa parte dos candidatos foram excluídos na primeira (75,4%) e segunda etapa (72,7%). Os principais critérios clínicos de exclusão foram: diarreia aguda recente, excesso de peso (IMC ≥25 kg/m2) e distúrbios gastrointestinais crônicos. Quatro dos 134 candidatos foram selecionados após a triagem completa, com taxa de detecção de doadores de 3%. Conclusão: A implantação de um CTMF, inédito no nosso meio, possibilita o acesso de pacientes com infecção recorrente e refratária pelo C. difficile a tratamento inovador, seguro, com elevada taxa de sucesso e pouco disponível no Brasil. A seleção apropriada de doadores qualificados é vital no processo de implantação de um CTMF. A avaliação clínica rigorosa dos doadores permitiu o uso racional de recursos para realização de exames laboratoriais. Um CTMF possibilita tratamento sob demanda, em maior escala, menos personalizados, com mais segurança e rastreabilidade. Este protocolo fornece subsídios para a realização de TMF em países emergentes.CNPq - Conselho Nacional de Desenvolvimento Científico e TecnológicoFAPEMIG - Fundação de Amparo à Pesquisa do Estado de Minas GeraisCAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível SuperiorOutra AgênciaengUniversidade Federal de Minas GeraisUFMGBrasilHCL - HOSPITAL DAS CLINICASMED - DEPARTAMENTO DE CLÍNICA MÉDICAVET - DEPARTAMENTO DE MEDICINA VETERINÁRIA PREVENTIVAArquivos de GastroenterologiaTransplante de microbiota fecalInfecções por clostridiumMicrobiotaMicrobioma gastrointestinalDiarreiaFezesFecal microbiota transplantationClostridium infectionsMicrobiotaGastrointestinal microbiomeDiarrheaFecesStructuring a fecal microbiota transplantation center in a university hospital in BrazilEstruturando um transplante de microbiota fecal centro em um hospital universitário no Brasilinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttps://www.scielo.br/j/ag/a/Rm6nW4JMwJhgHy5RCMCLV5K/?lang=enDaniel Antônio de Albuquerque TerraEduardo Garcia VilelaRodrigo Otávio Silveira SilvaLaiane Alves LeãoKarine Sampaio LimaRaissa Iglesias Fernandes Ângelo PassosAmanda Nadia DinizLuiz Gonzaga Vaz Coelhoapplication/pdfinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFMGinstname:Universidade Federal de Minas Gerais (UFMG)instacron:UFMGLICENSELicense.txtLicense.txttext/plain; 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dc.title.pt_BR.fl_str_mv Structuring a fecal microbiota transplantation center in a university hospital in Brazil
dc.title.alternative.pt_BR.fl_str_mv Estruturando um transplante de microbiota fecal centro em um hospital universitário no Brasil
title Structuring a fecal microbiota transplantation center in a university hospital in Brazil
spellingShingle Structuring a fecal microbiota transplantation center in a university hospital in Brazil
Daniel Antônio de Albuquerque Terra
Fecal microbiota transplantation
Clostridium infections
Microbiota
Gastrointestinal microbiome
Diarrhea
Feces
Transplante de microbiota fecal
Infecções por clostridium
Microbiota
Microbioma gastrointestinal
Diarreia
Fezes
title_short Structuring a fecal microbiota transplantation center in a university hospital in Brazil
title_full Structuring a fecal microbiota transplantation center in a university hospital in Brazil
title_fullStr Structuring a fecal microbiota transplantation center in a university hospital in Brazil
title_full_unstemmed Structuring a fecal microbiota transplantation center in a university hospital in Brazil
title_sort Structuring a fecal microbiota transplantation center in a university hospital in Brazil
author Daniel Antônio de Albuquerque Terra
author_facet Daniel Antônio de Albuquerque Terra
Eduardo Garcia Vilela
Rodrigo Otávio Silveira Silva
Laiane Alves Leão
Karine Sampaio Lima
Raissa Iglesias Fernandes Ângelo Passos
Amanda Nadia Diniz
Luiz Gonzaga Vaz Coelho
author_role author
author2 Eduardo Garcia Vilela
Rodrigo Otávio Silveira Silva
Laiane Alves Leão
Karine Sampaio Lima
Raissa Iglesias Fernandes Ângelo Passos
Amanda Nadia Diniz
Luiz Gonzaga Vaz Coelho
author2_role author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Daniel Antônio de Albuquerque Terra
Eduardo Garcia Vilela
Rodrigo Otávio Silveira Silva
Laiane Alves Leão
Karine Sampaio Lima
Raissa Iglesias Fernandes Ângelo Passos
Amanda Nadia Diniz
Luiz Gonzaga Vaz Coelho
dc.subject.por.fl_str_mv Fecal microbiota transplantation
Clostridium infections
Microbiota
Gastrointestinal microbiome
Diarrhea
Feces
topic Fecal microbiota transplantation
Clostridium infections
Microbiota
Gastrointestinal microbiome
Diarrhea
Feces
Transplante de microbiota fecal
Infecções por clostridium
Microbiota
Microbioma gastrointestinal
Diarreia
Fezes
dc.subject.other.pt_BR.fl_str_mv Transplante de microbiota fecal
Infecções por clostridium
Microbiota
Microbioma gastrointestinal
Diarreia
Fezes
description Background: Fecal microbiota transplantation (FMT) is an important therapeutic option for recurrent or refractory Clostridioides difficile infection, being a safe and effective method. Initial results suggest that FMT also plays an important role in other conditions whose pathogenesis involves alteration of the intestinal microbiota. However, its systematized use is not widespread, especially in Brazil. In the last decade, multiple reports and several cases emerged using different protocols for FMT, without standardization of methods and with variable response rates. In Brazil, few isolated cases of FMT have been reported without the implantation of a Fecal Microbiota Transplantation Center (FMTC). Objective: The main objective of this study is to describe the process of implanting a FMTC with a stool bank, in a Brazilian university hospital for treatment of recurrent and refractory C. difficile infection. Methods: The center was structured within the criteria required by international organizations such as the Food and Drug Administration, the European Fecal Microbiota Transplant Group and in line with national epidemiological and regulatory aspects. Results: A whole platform involved in structuring a transplant center with stool bank was established. The criteria for donor selection, processing and storage of samples, handling of recipients before and after the procedure, routes of administration, short and long-term follow-up of transplant patients were determined. Donor selection was conducted in three stages: pre-screening, clinical evaluation and laboratory screening. Most of the candidates were excluded in the first (75.4%) and second stage (72.7%). The main clinical exclusion criteria were: recent acute diarrhea, overweight (body mass index ≥25 kg/m2) and chronic gastrointestinal disorders. Four of the 134 candidates were selected after full screening, with a donor detection rate of 3%. Conclusion: The implantation of a transplant center, unprecedented in our country, allows the access of patients with recurrent or refractory C. difficile infection to innovative, safe treatment, with a high success rate and little available in Brazil. Proper selection of qualified donors is vital in the process of implementing a FMTC. The rigorous clinical evaluation of donors allowed the rational use of resources. A transplant center enables treatment on demand, on a larger scale, less personalized, with more security and traceability. This protocol provides subsidies for conducting FMT in emerging countries.
publishDate 2020
dc.date.issued.fl_str_mv 2020
dc.date.accessioned.fl_str_mv 2023-04-11T00:51:45Z
dc.date.available.fl_str_mv 2023-04-11T00:51:45Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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dc.identifier.uri.fl_str_mv http://hdl.handle.net/1843/51785
dc.identifier.doi.pt_BR.fl_str_mv https://doi.org/10.1590/S0004-2803.202000000-79
dc.identifier.issn.pt_BR.fl_str_mv 1678-4219
dc.identifier.orcid.pt_BR.fl_str_mv https://orcid.org/0000-0001-9691-6512
https://orcid.org/0000-0002-5443-7553
https://orcid.org/0000-0003-0074-2488
https://orcid.org/0000-0001-6547-3798
https://orcid.org/0000-0001-8897-3410
https://orcid.org/0000-0003-0705-5568
https://orcid.org/0000-0002-5287-5779
https://orcid.org/0000-0002-8721-7696
url https://doi.org/10.1590/S0004-2803.202000000-79
http://hdl.handle.net/1843/51785
https://orcid.org/0000-0001-9691-6512
https://orcid.org/0000-0002-5443-7553
https://orcid.org/0000-0003-0074-2488
https://orcid.org/0000-0001-6547-3798
https://orcid.org/0000-0001-8897-3410
https://orcid.org/0000-0003-0705-5568
https://orcid.org/0000-0002-5287-5779
https://orcid.org/0000-0002-8721-7696
identifier_str_mv 1678-4219
dc.language.iso.fl_str_mv eng
language eng
dc.relation.ispartof.pt_BR.fl_str_mv Arquivos de Gastroenterologia
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eu_rights_str_mv openAccess
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dc.publisher.none.fl_str_mv Universidade Federal de Minas Gerais
dc.publisher.initials.fl_str_mv UFMG
dc.publisher.country.fl_str_mv Brasil
dc.publisher.department.fl_str_mv HCL - HOSPITAL DAS CLINICAS
MED - DEPARTAMENTO DE CLÍNICA MÉDICA
VET - DEPARTAMENTO DE MEDICINA VETERINÁRIA PREVENTIVA
publisher.none.fl_str_mv Universidade Federal de Minas Gerais
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