메뉴 건너뛰기




Volumn 32, Issue 3, 2015, Pages 101-109

The regulation of fecal microbiota for transplantation: An international perspective for policy and public health

Author keywords

Clostridium difficile; fecal microbiota transplantation (FMT); Health Canada; microbiome; US Food and Drug Administration (FDA)

Indexed keywords

ANTIBIOTIC AGENT; BIOLOGICAL PRODUCT; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN; VANCOMYCIN;

EID: 84940529097     PISSN: 10601333     EISSN: 15322521     Source Type: Journal    
DOI: 10.3109/10601333.2015.1046602     Document Type: Review
Times cited : (16)

References (67)
  • 1
    • 20544444045 scopus 로고    scopus 로고
    • Diversity of the human intestinal microbial flora
    • Eckburg PB, Bik EM, Bernstein CN, et al. Diversity of the human intestinal microbial flora. Science 2005;308:1635-8.
    • (2005) Science , vol.308 , pp. 1635-1638
    • Eckburg, P.B.1    Bik, E.M.2    Bernstein, C.N.3
  • 2
    • 84866146940 scopus 로고    scopus 로고
    • Diversity, stability and resilience of the human gut microbiota
    • Lozupone CA, Stombaugh JI, Gordon JI, et al. Diversity, stability and resilience of the human gut microbiota. Nature 2012;489: 220-30.
    • (2012) Nature , vol.489 , pp. 220-230
    • Lozupone, C.A.1    Stombaugh, J.I.2    Gordon, J.I.3
  • 3
    • 84923918647 scopus 로고    scopus 로고
    • Review of the emerging treatment of clostridium difficile infection with fecal microbiota transplantation and insights into future challenges
    • Kassam Z, Lee CH, Hunt RH. Review of the emerging treatment of clostridium difficile infection with fecal microbiota transplantation and insights into future challenges. Clin Lab Med 2014;34:787-98.
    • (2014) Clin Lab Med , vol.34 , pp. 787-798
    • Kassam, Z.1    Lee, C.H.2    Hunt, R.H.3
  • 4
    • 84881557235 scopus 로고    scopus 로고
    • The adoptive transfer of behavioral phenotype via the intestinal microbiota: Experimental evidence and clinical implications
    • Collins SM, Kassam Z, Bercik P. The adoptive transfer of behavioral phenotype via the intestinal microbiota: experimental evidence and clinical implications. Curr Opin Microbiol 2013;16: 240-5.
    • (2013) Curr Opin Microbiol , vol.16 , pp. 240-245
    • Collins, S.M.1    Kassam, Z.2    Bercik, P.3
  • 5
    • 84864754089 scopus 로고    scopus 로고
    • Role of the intestinal microbiome in health and disease: From correlation to causation
    • Vos WM de, Vos EA de. Role of the intestinal microbiome in health and disease: from correlation to causation. Nutr Rev 2012;70(Suppl 1):S45-56.
    • (2012) Nutr Rev , vol.70 , pp. S45-56
    • De Vos, W.M.1    De Vos, E.A.2
  • 6
    • 84860003661 scopus 로고    scopus 로고
    • A meta-analysis of probiotic efficacy for gastrointestinal diseases
    • Ritchie ML, Romanuk TN. A meta-analysis of probiotic efficacy for gastrointestinal diseases. PLoS ONE 2012;7:e34938.
    • (2012) PLoS ONE , vol.7
    • Ritchie, M.L.1    Romanuk, T.N.2
  • 7
    • 84869395353 scopus 로고    scopus 로고
    • Should we standardize the 1,700-year-old fecal microbiota transplantation?
    • Zhang F, Luo W, Shi Y, et al. Should we standardize the 1,700-year-old fecal microbiota transplantation? Am J Gastroenterol 2012;107:1755-1755.
    • (2012) Am J Gastroenterol , vol.107 , pp. 1755-1755
    • Zhang, F.1    Luo, W.2    Shi, Y.3
  • 8
    • 84894241861 scopus 로고    scopus 로고
    • Policy: How to regulate faecal transplants
    • Smith MB, Kelly C, Alm EJ. Policy: how to regulate faecal transplants. Nature 2014;506:290-1.
    • (2014) Nature , vol.506 , pp. 290-291
    • Smith, M.B.1    Kelly, C.2    Alm, E.J.3
  • 9
    • 84897005978 scopus 로고    scopus 로고
    • Multistate Point-Prevalence Survey of health care-associated infections
    • Magill SS, Edwards JR, Bamberg W, et al. Multistate Point-Prevalence Survey of health care-associated infections. N Engl J Med 2014;370:1198-208.
    • (2014) N Engl J Med , vol.370 , pp. 1198-1208
    • Magill, S.S.1    Edwards, J.R.2    Bamberg, W.3
  • 10
    • 33748563622 scopus 로고    scopus 로고
    • The ESCMID Study Group for Clostridium difficile (ESGCD), EU Member States and the European Centre for Disease Prevention and Control (ECDC). Emergence of Clostridium difficile-associated disease in North America and Europe
    • Kuijper EJ, Coignard B, Tüll P. The ESCMID Study Group for Clostridium difficile (ESGCD), EU Member States and the European Centre for Disease Prevention and Control (ECDC). Emergence of Clostridium difficile-associated disease in North America and Europe. Clin Microbiol Infect 2006;12:2-18.
    • (2006) Clin Microbiol Infect , vol.12 , pp. 2-18
    • Kuijper, E.J.1    Coignard, B.2    Tüll, P.3
  • 11
    • 84898542092 scopus 로고    scopus 로고
    • Treatment of recurrent Clostridium difficile infection: A systematic review
    • O'Horo JC, Jindai K, Kunzer B, Safdar N. Treatment of recurrent Clostridium difficile infection: a systematic review. Infection 2013; 42:43-59.
    • (2013) Infection , vol.42 , pp. 43-59
    • O'Horo, J.C.1    Jindai, K.2    Kunzer, B.3    Safdar, N.4
  • 12
    • 84863923754 scopus 로고    scopus 로고
    • Decreased cure and increased recurrence rates for Clostridium difficile infection caused by the epidemic C
    • Petrella LA, Sambol SP, Cheknis A, et al. Decreased cure and increased recurrence rates for Clostridium difficile infection caused by the epidemic C. difficile BI Strain. Clin Infect Dis 2012;55: 351-7.
    • (2012) Difficile BI Strain. Clin Infect Dis , vol.55 , pp. 351-357
    • Petrella, L.A.1    Sambol, S.P.2    Cheknis, A.3
  • 13
    • 79551527297 scopus 로고    scopus 로고
    • Fidaxomicin versus Vancomycin for Clostridium difficile Infection
    • Louie TJ, Miller MA, Mullane KM, et al. Fidaxomicin versus Vancomycin for Clostridium difficile Infection. N Engl J Med 2011;364:422-31.
    • (2011) N Engl J Med , vol.364 , pp. 422-431
    • Louie, T.J.1    Miller, M.A.2    Mullane, K.M.3
  • 14
    • 19344363493 scopus 로고    scopus 로고
    • Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada
    • Pépin J, Alary M-E, Valiquette L, et al. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis 2005;40:1591-7.
    • (2005) Clin Infect Dis , vol.40 , pp. 1591-1597
    • Pépin, J.1    Alary, M.-E.2    Valiquette, L.3
  • 15
    • 84896708902 scopus 로고    scopus 로고
    • Microbiota dynamics in patients treated with fecal microbiota transplantation for recurrent Clostridium difficile infection
    • Song Y, Garg S, Girotra M, et al. Microbiota dynamics in patients treated with fecal microbiota transplantation for recurrent Clostridium difficile infection. PLoS ONE 2013;8:e81330.
    • (2013) PLoS ONE , vol.8
    • Song, Y.1    Garg, S.2    Girotra, M.3
  • 16
    • 39349107697 scopus 로고    scopus 로고
    • Decreased diversity of the fecal microbiome in recurrent Clostridium difficile- Associated diarrhea
    • Chang JY, Antonopoulos DA, Kalra A, et al. decreased diversity of the fecal microbiome in recurrent Clostridium difficile- Associated diarrhea. J Infect Dis 2008;197:435-8.
    • (2008) J Infect Dis , vol.197 , pp. 435-438
    • Chang, J.Y.1    Antonopoulos, D.A.2    Kalra, A.3
  • 17
    • 77951700268 scopus 로고    scopus 로고
    • Changes in the composition of the human fecal microbiome after bacteriotherapy for recurrent Clostridium difficile-associated diarrhea
    • Khoruts A, Dicksved J, Jansson JK, Sadowsky MJ. Changes in the composition of the human fecal microbiome after bacteriotherapy for recurrent Clostridium difficile-associated diarrhea. J Clin Gastroenterol 2010;44:354-60.
    • (2010) J Clin Gastroenterol , vol.44 , pp. 354-360
    • Khoruts, A.1    Dicksved, J.2    Jansson, J.K.3    Sadowsky, M.J.4
  • 18
    • 84904264732 scopus 로고    scopus 로고
    • Canadian Association of Gastroenterology position statement: Fecal microbiota transplant therapy
    • Moayyedi P, Marshall JK, Yuan Y, Hunt R. Canadian Association of Gastroenterology position statement: fecal microbiota transplant therapy. Can J Gastroenterol Hepatol 2014;28:66-8.
    • (2014) Can J Gastroenterol Hepatol , vol.28 , pp. 66-68
    • Moayyedi, P.1    Marshall, J.K.2    Yuan, Y.3    Hunt, R.4
  • 19
    • 84875952542 scopus 로고    scopus 로고
    • Fecal microbiota transplantation for Clostridium difficile infection: Systematic review and meta-analysis
    • Kassam Z, Lee CH, Yuan Y, Hunt RH. Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. Am J Gastroenterol 2013;108:500-8.
    • (2013) Am J Gastroenterol , vol.108 , pp. 500-508
    • Kassam, Z.1    Lee, C.H.2    Yuan, Y.3    Hunt, R.H.4
  • 20
    • 84863719891 scopus 로고    scopus 로고
    • Long-term follow-up of colonoscopic fecal microbiota transplant for recurrent Clostridium difficile infection
    • Brandt LJ, Aroniadis OC, Mellow M, et al. Long-term follow-up of colonoscopic fecal microbiota transplant for recurrent Clostridium difficile infection. Am J Gastroenterol 2012;107:1079-87.
    • (2012) Am J Gastroenterol , vol.107 , pp. 1079-1087
    • Brandt, L.J.1    Aroniadis, O.C.2    Mellow, M.3
  • 21
    • 84898906169 scopus 로고    scopus 로고
    • Systematic review: Faecal microbiota transplantation therapy for digestive and nondigestive disorders in adults and children
    • Sha S, Liang J, Chen M, et al. Systematic review: faecal microbiota transplantation therapy for digestive and nondigestive disorders in adults and children. Aliment Pharmacol Ther 2014;39:1003-32.
    • (2014) Aliment Pharmacol Ther , vol.39 , pp. 1003-1032
    • Sha, S.1    Liang, J.2    Chen, M.3
  • 22
    • 84873019302 scopus 로고    scopus 로고
    • Duodenal infusion of donor feces for recurrent Clostridium difficile
    • 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.
    • (2013) N Engl J Med , vol.368 , pp. 407-415
    • Van Nood, E.1    Vrieze, A.2    Nieuwdorp, M.3
  • 23
    • 84940471101 scopus 로고    scopus 로고
    • Rescue therapy with fecal microbiota transplantation in hospitalized patients with severe and severe-complicated Clostridium difficile infection
    • Fischer M, Cook G, Rogers N, et al. Rescue therapy with fecal microbiota transplantation in hospitalized patients with severe and severe-complicated Clostridium difficile infection. Am J Gastroenterol 2014;109:S195.
    • (2014) Am J Gastroenterol , vol.109 , pp. S195
    • Fischer, M.1    Cook, G.2    Rogers, N.3
  • 24
    • 84918584474 scopus 로고    scopus 로고
    • Fecal microbiota transplantation as therapy for inflammatory bowel disease: A systematic review and metaanalysis
    • Colman RJ, Rubin DT. Fecal microbiota transplantation as therapy for inflammatory bowel disease: a systematic review and metaanalysis. J Crohns Colitis 2014;8:1569-81.
    • (2014) J Crohns Colitis , vol.8 , pp. 1569-1581
    • Colman, R.J.1    Rubin, D.T.2
  • 25
    • 84880282496 scopus 로고    scopus 로고
    • An overview of fecal microbiota transplantation: Techniques, indications, and outcomes
    • Brandt LJ, Aroniadis OC. An overview of fecal microbiota transplantation: techniques, indications, and outcomes. Gastrointest Endosc 2013;78:240-9.
    • (2013) Gastrointest Endosc , vol.78 , pp. 240-249
    • Brandt, L.J.1    Aroniadis, O.C.2
  • 26
    • 84866738529 scopus 로고    scopus 로고
    • Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome
    • e7
    • Vrieze A, Van Nood E, Holleman F, et al. Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome. Gastroenterology 2012;143: 913-16.e7.
    • (2012) Gastroenterology , vol.143 , pp. 913-916
    • Vrieze, A.1    Van Nood, E.2    Holleman, F.3
  • 27
    • 77950251400 scopus 로고    scopus 로고
    • A human gut microbial gene catalogue established by metagenomic sequencing
    • Qin J, Li R, Raes J, et al. A human gut microbial gene catalogue established by metagenomic sequencing. Nature 2010;464:59-65.
    • (2010) Nature , vol.464 , pp. 59-65
    • Qin, J.1    Li, R.2    Raes, J.3
  • 28
    • 84910057313 scopus 로고    scopus 로고
    • Host lifestyle affects human microbiota on daily timescales
    • David LA, Materna AC, Friedman J, et al. Host lifestyle affects human microbiota on daily timescales. Genome Biol 2014;15:R89.
    • (2014) Genome Biol , vol.15 , pp. R89
    • David, L.A.1    Materna, A.C.2    Friedman, J.3
  • 29
    • 33744804299 scopus 로고    scopus 로고
    • Metagenomic analysis of the human distal gut microbiome
    • Gill SR, Pop M, DeBoy RT, et al. Metagenomic Analysis of the Human Distal Gut Microbiome. Science 2006;312:1355-9.
    • (2006) Science , vol.312 , pp. 1355-1359
    • Gill, S.R.1    Pop, M.2    DeBoy, R.T.3
  • 31
    • 84940485295 scopus 로고    scopus 로고
    • How to safely do a fecal transplant at home-DIY Instructions [Internet]
    • Available online at accessed 13 January 2015
    • How to safely do a fecal transplant at home-DIY Instructions [Internet]. The Power of Poop, 2013. Available online at: http://thepowerofpoop.com/epatients/fecal-transplant-instructions/, accessed 13 January 2015.
    • (2013) The Power of Poop
  • 32
    • 84940506949 scopus 로고    scopus 로고
    • Available online at accessed 31 January 2015
    • HomeFMT. FECAL TRANSPLANT (FMT) [Internet]. 2013. Available online at: https://www.youtube.com/watch?v= xLIndT7fuGo&feature=youtube-gdata-player, accessed 31 January 2015.
    • (2013)
    • HomeFMT. FECAL TRANSPLANT (FMT) [Internet]1
  • 34
    • 41649086195 scopus 로고    scopus 로고
    • Regulating off-label drug use - Rethinking the role of the FDA
    • Stafford RS. Regulating off-label drug use - Rethinking the role of the FDA. N Engl J Med 2008;358:1427-9.
    • (2008) N Engl J Med , vol.358 , pp. 1427-1429
    • Stafford, R.S.1
  • 35
    • 32944466887 scopus 로고    scopus 로고
    • Ecological and evolutionary forces shaping microbial diversity in the human intestine
    • Ley RE, Peterson DA, Gordon JI. Ecological and evolutionary forces shaping microbial diversity in the human intestine. Cell 2006;124:837-48.
    • (2006) Cell , vol.124 , pp. 837-848
    • Ley, R.E.1    Peterson, D.A.2    Gordon, J.I.3
  • 36
    • 15544369658 scopus 로고    scopus 로고
    • Host-bacterial mutualism in the human intestine
    • Bäckhed F, Ley RE, Sonnenburg JL, et al. Host-bacterial mutualism in the human intestine. Science 2005;307:1915-20.
    • (2005) Science , vol.307 , pp. 1915-1920
    • Bäckhed, F.1    Ley, R.E.2    Sonnenburg, J.L.3
  • 40
    • 79952763661 scopus 로고    scopus 로고
    • Succession of microbial consortia in the developing infant gut microbiome
    • Koenig JE, Spor A, Scalfone N, et al. Succession of microbial consortia in the developing infant gut microbiome. Proc Natl Acad Sci 2011;108(Suppl 1):4578-85.
    • (2011) Proc Natl Acad Sci , vol.108 , pp. 4578-4585
    • Koenig, J.E.1    Spor, A.2    Scalfone, N.3
  • 41
    • 84862276328 scopus 로고    scopus 로고
    • Structure, function and diversity of the healthy human microbiome
    • Human Microbiome Project Consortium. Structure, function and diversity of the healthy human microbiome. Nature 2012;486: 207-14.
    • (2012) Nature , vol.486 , pp. 207-214
    • Human Microbiome Project Consortium1
  • 42
    • 84858439578 scopus 로고    scopus 로고
    • The Human Microbiome: At the interface of health and disease
    • Cho I, Blaser MJ. The Human Microbiome: at the interface of health and disease. Nat Rev Genet 2012;13:260-70.
    • (2012) Nat Rev Genet , vol.13 , pp. 260-270
    • Cho, I.1    Blaser, M.J.2
  • 43
  • 46
    • 84907230211 scopus 로고    scopus 로고
    • Cambridge, MA: Harvard University Pres
    • Swanson KW. Banking on the Body. Cambridge, MA: Harvard University Press; 2014.
    • (2014) Banking on the Body
    • Swanson, K.W.1
  • 49
    • 84871909211 scopus 로고    scopus 로고
    • Washington DC: Washington Post;. Available online at accessed 16 April 2015
    • Whoriskey P. Anemia drug made billions, but at what cost? [Internet]. Washington DC: Washington Post; 2012. Available online at: http://www.washingtonpost.com/business/economy/anemia-drug-made-billions-but-at-what-cost/2012/07/19/gJQAX5yqwW-story.html, accessed 16 April 2015.
    • (2012) Anemia Drug Made Billions, but at What Cost? [Internet]
    • Whoriskey, P.1
  • 54
    • 84866299836 scopus 로고    scopus 로고
    • A Canadian Working Group report on fecal microbial therapy: Microbial ecosystems therapeutics
    • Allen-Vercoe E, Reid G, Viner N, et al. A Canadian Working Group report on fecal microbial therapy: microbial ecosystems therapeutics. Can J Gastroenterol 2012;26:457-62.
    • (2012) Can J Gastroenterol , vol.26 , pp. 457-462
    • Allen-Vercoe, E.1    Reid, G.2    Viner, N.3
  • 56
    • 84940475193 scopus 로고    scopus 로고
    • Toronto ON: Globe Mail;. Available online at/, accessed 3 February 2015
    • Stueck W. B.C. health authority halts fecal transplants [Internet]. Toronto ON: Globe Mail; 2014. Available online at: http://www.theglobeandmail.com/news/british-columbia/health-authority-halts-fecal-transplants/article18317566/, accessed 3 February 2015.
    • (2014) Health Authority Halts Fecal Transplants [Internet]
    • Stueck, W.B.C.1
  • 58
    • 84940481110 scopus 로고    scopus 로고
    • Government of Canada: Health Canada;. Available online at accessed 3 February 2015.
    • Fees for the review of drug submissions, supplements, and applications [Internet]. Government of Canada: Health Canada; 2009. Available online at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/feef-fraisf-eng.php, accessed 3 February 2015.
    • (2009) Fees for the Review of Drug Submissions, Supplements, and Applications [Internet]
  • 59
    • 84887259304 scopus 로고    scopus 로고
    • European Society of Clinical Microbiology and Infectious Diseases: Update of the treatment guidance document for Clostridium difficile infection
    • Debast SB, Bauer MP, Kuijper EJ. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect Dis. 2014;20(Suppl 2):1-26.
    • (2014) Clin Microbiol Infect Dis. , vol.20 , pp. 1-26
    • Debast, S.B.1    Bauer, M.P.2    Kuijper, E.J.3
  • 61
    • 84940552440 scopus 로고    scopus 로고
    • Transplantation de microbiote fécal
    • Paris, France: L'Agence nationale de sécurité du médicament et des produits de santé (ANSM); Available online at: accessed 21 January 2015
    • comité scientifique spécialisé temporaire (CSST) «Transplantation de microbiote fécal». La transplantation de microbiote fécal et son encadrement dans les essais cliniques [Internet]. Paris, France: L'Agence nationale de sécurité du médicament et des produits de santé (ANSM); 2014. Available online at: http://ansm.sante.fr/var/ansm-site/storage/original/application/5e5e01018303790194275 ded0e02353c.pdf, accessed 21 January 2015.
    • (2014) La Transplantation de Microbiote Fécal et Son Encadrement dans les Essais Cliniques [Internet]
    • comité scientifique spécialisé temporaire (CSST)1
  • 62
    • 84940497130 scopus 로고    scopus 로고
    • Symonston, Australia: Therapeutic Goods Administration;. Available online at, accessed 7 January 2015
    • Hogg G. Comments on the New Regulatory Framework for IVDs including on the proposed amendments [Internet]. Symonston, Australia: Therapeutic Goods Administration; 2013. Available online at: https://www.tga.gov.au/sites/default/files/consult-ivdregulatory-framework-130503-submission-mdu-phl.pdf, accessed 7 January 2015.
    • (2013) Comments on the New Regulatory Framework for IVDs Including on the Proposed Amendments [Internet]
    • Hogg, G.1
  • 65
    • 84900434000 scopus 로고    scopus 로고
    • Cost-effectiveness of competing strategies for management of recurrent Clostridium difficile infection: A decision analysis
    • Konijeti GG, Sauk J, Shrime MG, et al. Cost-effectiveness of competing strategies for management of recurrent Clostridium difficile infection: a decision analysis. Clin Infect Dis 2014;58:1507-14.
    • (2014) Clin Infect Dis , vol.58 , pp. 1507-1514
    • Konijeti, G.G.1    Sauk, J.2    Shrime, M.G.3
  • 66
    • 84884597711 scopus 로고    scopus 로고
    • Atlanta, GA: Centers for Disease Control and Prevention;. Available online at, accessed 7 January 2015
    • Antibiotic Resistance Threats in the United States, 2013 [Internet]. Atlanta, GA: Centers for Disease Control and Prevention; 2013. Available online at: http://www.cdc.gov/drugresistance/threatreport-2013/pdf/ar-threats-2013-508.pdf, accessed 7 January 2015.
    • (2013) Antibiotic Resistance Threats in the United States, 2013 [Internet]
  • 67
    • 84903783846 scopus 로고    scopus 로고
    • Faecal microbiota transplantation: A sui generis biological drug, not a tissue
    • Megerlin F, Fouassier E, Lopert R, Bourlioux P. Faecal microbiota transplantation: a sui generis biological drug, not a tissue. Ann Pharm Fr 2014;72:217-20.
    • (2014) Ann Pharm Fr , vol.72 , pp. 217-220
    • Megerlin, F.1    Fouassier, E.2    Lopert, R.3    Bourlioux, P.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.