Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook

Gastroenterology

Volumn 149, Issue 1, 2015, Pages 223-237

  Kelly, Colleen R ^a   Kahn, Stacy ^b   Kashyap, Purna ^c   Laine, Loren ^d,e   Rubin, David ^b   Atreja, Ashish ^f   Moore, Thomas ^g   Wu, Gary ^h  

^a BROWN UNIVERSITY   (United States)

^b UNIVERSITY OF CHICAGO   (United States)

^c MAYO CLINIC   (United States)

^d YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e VA CONNECTICUT HEALTHCARE SYSTEM   (United States)

^f MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^g Infectious Disease Consultants   (United States)

^h UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Fecal Transplant; FMT; Gut Microbial Therapeutics

Indexed keywords

CEFOPERAZONE; CIPROFLOXACIN; VANCOMYCIN;

ADVERSE OUTCOME; ANTIMICROBIAL THERAPY; CLINICAL TRIAL (TOPIC); CLOSTRIDIUM DIFFICILE INFECTION; DONOR; DONOR SELECTION; FECAL MICROBIOTA TRANSPLANTATION; FECES MICROFLORA; HISTORY; HUMAN; INFLAMMATORY BOWEL DISEASE; IRRITABLE COLON; LETTER; META ANALYSIS (TOPIC); METHODOLOGY; MULTICENTER STUDY (TOPIC); NONHUMAN; OBESITY; PATIENT SAFETY; PERCEPTION; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SCREENING; SYSTEMATIC REVIEW (TOPIC); TRANSPLANTATION; TREATMENT INDICATION; ADULT; BIOLOGICAL THERAPY; CLOSTRIDIUM INFECTIONS; FECES; FEMALE; ISOLATION AND PURIFICATION; MALE; MICROBIOLOGY; MICROFLORA; MIDDLE AGED; PATHOGENICITY; PEPTOCLOSTRIDIUM DIFFICILE; PROCEDURES;

ADULT; BIOLOGICAL THERAPY; CLOSTRIDIUM DIFFICILE; CLOSTRIDIUM INFECTIONS; FECES; FEMALE; HUMANS; MALE; MICROBIOTA; MIDDLE AGED;

EID: 84931295496     PISSN: 00165085     EISSN: 15280012     Source Type: Journal    
DOI: 10.1053/j.gastro.2015.05.008     Document Type: Article

References (118)

1. F. Backhed, R.E. Ley, and J.L. Sonnenburg Host-bacterial mutualism in the human intestine Science 307 2005 1915 1920
2. R.E. Ley, D.A. Peterson, and J.I. Gordon Ecological and evolutionary forces shaping microbial diversity in the human intestine Cell 124 2006 837 848
3. G. Cammarota, G. Ianiro, and A. Gasbarrini Fecal microbiota transplantation for the treatment of Clostridium difficile infection: a systematic review J Clin Gastroenterol 48 2014 693 702
4. E. Van Nood, A. Vrieze, and M. Nieuwdorp Duodenal infusion of donor feces for recurrent Clostridium difficile N Engl J Med 368 2013 407 415
5. Z. Kassam, C.H. Lee, and Y. Yuan Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis Am J Gastroenterol 108 2013 500 508
6. A. Khoruts, J. Dicksved, and J.K. Jansson Changes in the composition of the human fecal microbiome after bacteriotherapy for recurrent Clostridium difficile-associated diarrhea J Clin Gastroenterol 44 2010 354 360
7. M.J. Hamilton, A.R. Weingarden, and T. Unno High-throughput DNA sequence analysis reveals stable engraftment of gut microbiota following transplantation of previously frozen fecal bacteria Gut Microbes 4 2013 125 135
8. F. Zhang, W. Luo, and Y. Shi Should we standardize the 1,700-year-old fecal microbiota transplantation? Am J Gastroenterol 107 2012 1755
9. E.J. DePeters, and L.W. George Rumen transfaunation Immunol Lett 162 2014 69 76
10. B. Eiseman, W. Silen, and G.S. Bascom Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis Surgery 44 1958 854 859
11. A. Schwan, S. Sjolin, and U. Trottestam Relapsing Clostridium difficile enterocolitis cured by rectal infusion of homologous faeces Lancet 2 1983 845
12. F.C. Lessa, Y. Mu, and W.M. Bamberg Burden of Clostridium difficile infection in the United States N Engl J Med 372 2015 825 834
13. M. Warny, J. Pepin, and A. Fang Toxin production by an emerging strain of Clostridium difficile associated with outbreaks of severe disease in North America and Europe Lancet 366 2005 1079 1084
14. V.K. Ridaura, J.J. Faith, and F.E. Rey Gut microbiota from twins discordant for obesity modulate metabolism in mice Science 341 2013 1241214
15. ClinicalTrials.gov. Clinical trials for fecal transplant. Available at: https://clinicaltrials.gov/ct2/results?term=fecal+transplant&Search=Search. Accessed May 1, 2015.
16. J.S. Bakken, T. Borody, and L.J. Brandt Treating Clostridium difficile infection with fecal microbiota transplantation Clin Gastroenterol Hepatol 9 2011 1044 1049
17. C.M. Surawicz, L.J. Brandt, and D.G. Binion Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections Am J Gastroenterol 108 2013 478 498 quiz 499
18. D.M. You, M.A. Franzos, and R.P. Holman Successful treatment of fulminant Clostridium difficile infection with fecal bacteriotherapy Ann Intern Med 148 2008 632 633
19. A.R. Weingarden, M.J. Hamilton, and M.J. Sadowsky Resolution of severe Clostridium difficile infection following sequential fecal microbiota transplantation J Clin Gastroenterol 47 2013 735 737
20. J.A. Trubiano, B. Gardiner, and J.C. Kwong Faecal microbiota transplantation for severe Clostridium difficile infection in the intensive care unit Eur J Gastroenterol Hepatol 25 2013 255 257
21. K. Neemann, D.D. Eichele, and P.W. Smith Fecal microbiota transplantation for fulminant Clostridium difficile infection in an allogeneic stem cell transplant patient Transpl Infect Dis 14 2012 E161 E165
22. K.A. Dorsey, E.D. Moritz, and W.R. Steele A comparison of human immunodeficiency virus, hepatitis C virus, hepatitis B virus, and human T-lymphotropic virus marker rates for directed versus volunteer blood donations to the American Red Cross during 2005 to 2010 Transfusion 53 2013 1250 1256
23. I. Youngster, G.H. Russell, and C. Pindar Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection JAMA 312 2014 1772 1778
24. J. Aas, C.E. Gessert, and J.S. Bakken Recurrent Clostridium difficile colitis: case series involving 18 patients treated with donor stool administered via a nasogastric tube Clin Infect Dis 36 2003 580 585
25. A. Gustafsson, A. Berstad, and S. Lund-Tonnesen The effect of faecal enema on five microflora-associated characteristics in patients with antibiotic-associated diarrhoea Scand J Gastroenterol 34 1999 580 586
26. T.A. Rubin, C.E. Gessert, and J. Aas Fecal microbiome transplantation for recurrent Clostridium difficile infection: report on a case series Anaerobe 19 2013 22 26
27. A.A. MacConnachie, R. Fox, and D.R. Kennedy Faecal transplant for recurrent Clostridium difficile-associated diarrhoea: a UK case series Q J Med 102 2009 781 784
28. G. Russell, J. Kaplan, and M. Ferraro Fecal bacteriotherapy for relapsing Clostridium difficile infection in a child: a proposed treatment protocol Pediatrics 126 2010 e239 e242
29. M.P. Kronman, H.J. Nielson, and A.L. Adler Fecal microbiota transplantation via nasogastric tube for recurrent Clostridium difficile infection in pediatric patients J Pediatr Gastroenterol Nutr 60 2015 23 26
30. S.E. Persky, and L.J. Brandt Treatment of recurrent Clostridium difficile-associated diarrhea by administration of donated stool directly through a colonoscope Am J Gastroenterol 95 2000 3283 3285
31. S.S. Yoon, and L.J. Brandt Treatment of refractory/recurrent C. difficile-associated disease by donated stool transplanted via colonoscopy: a case series of 12 patients J Clin Gastroenterol 44 2010 562 566
32. L.J. Brandt, O.C. Aroniadis, and M. Mellow Long-term follow-up of colonoscopic fecal microbiota transplant for recurrent Clostridium difficile infection Am J Gastroenterol 107 2012 1079 1087
33. F. Rohlke, C.M. Surawicz, and N. Stollman Fecal flora reconstitution for recurrent Clostridium difficile infection: results and methodology J Clin Gastroenterol 44 2010 567 570
34. C.R. Kelly, L. de Leon, and N. Jasutkar Fecal microbiota transplantation for relapsing Clostridium difficile infection in 26 patients: methodology and results J Clin Gastroenterol 46 2012 145 149
35. E. Mattila, R. Uusitalo-Seppälä, and M. Wuorela Fecal transplantation, through colonoscopy, is effective therapy for recurrent Clostridium difficile infection Gastroenterology 142 2012 490 496
36. Z. Kassam, R. Hundal, and J.K. Marshall Fecal transplant via retention enema for refractory or recurrent Clostridium difficile infection Arch Intern Med 172 2012 191 193
37. M.S. Silverman, I. Davis, and D.R. Pillai Success of self-administered home fecal transplantation for chronic Clostridium difficile infection Clin Gastroenterol Hepatol 8 2010 471 473
38. T.A. Bowden Jr., A.R. Mansberger Jr., and L.E. Lykins Pseudomembraneous enterocolitis: mechanism for restoring floral homeostasis Am Surg 47 1981 178 183
39. C.H. Lee, J.E. Belanger, and Z. Kassam The outcome and long-term follow-up of 94 patients with recurrent and refractory Clostridium difficile infection using single to multiple fecal microbiota transplantation via retention enema Eur J Clin Microbiol Infect Dis 33 2014 1425 1428
40. S.K. Dutta, M. Girotra, and S. Garg Efficacy of combined jejunal and colonic fecal microbiota transplantation for recurrent Clostridium difficile infection Clin Gastroenterol Hepatol 12 2014 1572 1576
41. R.U. Varier, E. Biltaji, and K.J. Smith Cost-effectiveness analysis of treatment strategies for initial Clostridium difficile infection Clin Microbiol Infect 20 2014 1343 1351
42. C.R. Kelly, C. Ihunnah, and M. Fischer Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients Am J Gastroenterol 109 2014 1065 1071
43. I. Youngster, J. Sauk, and C. Pindar Fecal microbiota transplant for relapsing Clostridium difficle infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study Clin Infect Dis 58 2014 1515 1522
44. J.Y. Chang, D.A. Antonopoulos, and A. Kalra Decreased diversity of the fecal microbiome in recurrent Clostridium difficile associated diarrhea J Infect Dis 197 2008 435 438
45. M. Rupnik, M.H. Wilcox, and D.N. Gerding Clostridium difficile infection: new developments in epidemiology and pathogenesis Nat Rev Microbiol 7 2009 526 536
46. L. Dethlefsen, S. Huse, and M.L. Sogin The pervasive effects of an antibiotic on the human gut microbiota, as revealed by deep 16S rRNA sequencing PLoS Biol 6 2008 e280
47. C.M. Theriot, M.J. Koenigsknecht, and P.E. Carlson Jr. Antibiotic-induced shifts in the mouse gut microbiome and metabolome increase susceptibility to Clostridium difficile infection Nat Commun 5 2014 3114
48. S. Khanna, D.S. Pardi, and S.L. Aronson The epidemiology of community-acquired Clostridium difficile infection: a population-based study Am J Gastroenterol 107 2012 89 95
49. D. Shahinas, M. Silverman, and T. Sittler Toward an understanding of changes in diversity associated with fecal microbiome transplantation based on 16S rRNA gene deep sequencing mBio 3 5 2012
50. A.E. Reeves, M.J. Koenigsknecht, and I.L. Bergin Suppression of Clostridium difficile in the gastrointestinal tracts of germfree mice inoculated with a murine isolate from the family Lachnospiraceae Infect Immun 80 2012 3786 3794
51. T.D. Lawley, S. Clare, and A.W. Walker Targeted restoration of the intestinal microbiota with a simple, defined bacteriotherapy resolves relapsing Clostridium difficile disease in mice PLoS Pathog 8 2012 e1002995
52. M.C. Rea, C.S. Sit, and E. Clayton Thuricin CD, a posttranslationally modified bacteriocin with a narrow spectrum of activity against Clostridium difficile Proc Natl Acad Sci U S A 107 2010 9352 9357
53. C.G. Buffie, V. Bucci, and R.R. Stein Precision microbiome reconstitution restores bile acid mediated resistance to Clostridium difficile Nature 517 2015 205 208
54. F.C. Wallis The surgery of colitis Br Med J 1 1909 10 13
55. N.A. Nagalingam, and S.V. Lynch Role of the microbiota in inflammatory bowel diseases Inflamm Bowel Dis 18 2012 968 984
56. A.D. Kostic, R.J. Xavier, and D. Gevers The microbiome in inflammatory bowel disease: current status and the future ahead Gastroenterology 146 2014 1489 1499
57. C. Manichanh, N. Borruel, and F. Casellas The gut microbiota in IBD Nat Rev Gastroenterol Hepatol 9 2012 599 608
58. D.N. Frank, A.L. St Amand, and R.A. Feldman Molecular-phylogenetic characterization of microbial community imbalances in human inflammatory bowel diseases Proc Natl Acad Sci U S A 104 2007 13780 13785
59. H. Sokol, B. Pigneur, and L. Watterlot Faecalibacterium prausnitzii is an anti-inflammatory commensal bacterium identified by gut microbiota analysis of Crohn disease patients Proc Natl Acad Sci U S A 105 2008 16731 16736
60. J.D. Bennet, and M. Brinkman Treatment of ulcerative colitis by implantation of normal colonic flora Lancet 1 1989 164
61. T.J. Borody, L. George, and P. Andrews Bowel-flora alteration: a potential cure for inflammatory bowel disease and irritable bowel syndrome? Med J Aust 150 1989 604
62. T.J. Borody, E.F. Warren, and S. Leis Treatment of ulcerative colitis using fecal bacteriotherapy J Clin Gastroenterol 37 2003 42 47
63. F.-M. Zhang, H.-G. Wang, and M. Wang Fecal microbiota transplantation for severe enterocolonic fistulizing Crohn's disease World J Gastroenterol 19 2013 7213
64. C. Damman, M. Brittnacher, and H. Hayden Single colonoscopically administered fecal microbiota transplant for ulcerative colitis - a pilot study to determine therapeutic benefit and graft stability (abstr) Gastroenterology 146 2014 S-460
65. B.P. Vaughn, D. Gevers, and A. Ting Fecal microbiota transplantation induces early improvement in symptoms in patients with active Crohn's disease (abstr) Gastroenterology 146 2014 S-591 S-592
66. D.L. Suskind, N. Singh, and H. Nielson Fecal microbial transplant via nasogastric tube for active pediatric ulcerative colitis J Pediatr Gastroenterol Nutr 60 2015 27 29
67. S. Vermeire, M. Joossens, and K. Verbeke Pilot study on the safety and efficacy of faecal microbiota transplantation in refractory Crohn's disease (abstr) Gastroenterology 142 2012 S-360
68. S. Kunde, A. Pham, and S. Bonczyk Safety, tolerability, and clinical response after fecal transplantation in children and young adults with ulcerative colitis J Pediatr Gastroenterol Nutr 56 2013 597 601
69. P.K. Kump, H.P. Grochenig, and S. Lackner Alteration of intestinal dysbiosis by fecal microbiota transplantation does not induce remission in patients with chronic active ulcerative colitis Inflamm Bowel Dis 19 2013 2155 2165
70. S. Angelberger, W. Reinisch, and A. Makristathis Temporal bacterial community dynamics vary among ulcerative colitis patients after fecal microbiota transplantation Am J Gastroenterol 108 2013 1620 1630
71. J. Landy, H.O. Al-Hassi, and E.R. Mann A prospective controlled pilot study of fecal microbiota transplantation for chronic refractory pouchitis (abstr) Gastroenterology 144 2013 S-897
72. R.J. Colman, and D.T. Rubin Fecal microbiota transplantation as therapy for inflammatory bowel disease: a systematic review and meta-analysis J Crohns Colitis 8 2014 1569 1581
73. D.L. Suskind, M.J. Brittnacher, and G. Wahbeh Fecal microbial transplant effect on clinical outcomes and fecal microbiome in active Crohn's disease Inflamm Bowel Dis 21 2015 556 563
74. L.M. De Leon, J.B. Watson, and C.R. Kelly Transient flare of ulcerative colitis after fecal microbiota transplantation for recurrent Clostridium difficile infection Clin Gastroenterol Hepatol 11 2013 1036 1038
75. C.R. Kelly, H. Ziud, and S. Kahn New diagnosis of Crohn's colits 6 weeks after fecal microbiota transplantation (abstr) Inflamm Bowel Dis 20 2014 S21
76. P. Moayyedi, M.G. Surette, and P.T. Kim Fecal microbiota transplantation induces remission in patients with active ulcerative colitis in a randomized, controlled trial Gastroenterology 149 2015 102 109
77. N.G. Rossen, S. Fuentes, and M.J. van der Spek Findings from a randomized controlled trial of fecal transplantation for patients with ulcerative colitis Gastroenterology 149 2015 110 118
78. P.T. James, R. Leach, and E. Kalamara The worldwide obesity epidemic Obes Res 9 suppl 4 2001 228s 233s
79. P.J. Turnbaugh, R.E. Ley, and M.A. Mahowald An obesity-associated gut microbiome with increased capacity for energy harvest Nature 444 2006 1027 1031
80. I. Cho, S. Yamanishi, and L. Cox Antibiotics in early life alter the murine colonic microbiome and adiposity Nature 488 2012 621 626
81. A.P. Liou, M. Paziuk, and J.M. Luevano Jr. Conserved shifts in the gut microbiota due to gastric bypass reduce host weight and adiposity Sci Transl Med 5 2013 178ra41
82. A.W. Walker, and J. Parkhill Microbiology. Fighting obesity with bacteria Science 341 2013 1069 1070
83. A. Vrieze, E. Van Nood, and F. Holleman Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome Gastroenterology 143 2012 913 916.e7
84. A.P. Hungin, L. Chang, and G.R. Locke Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact Aliment Pharmacol Ther 21 2005 1365 1375
85. J. Matto, L. Maunuksela, and K. Kajander Composition and temporal stability of gastrointestinal microbiota in irritable bowel syndrome - a longitudinal study in IBS and control subjects FEMS Immunol Med Microbiol 43 2005 213 222
86. A. Balsari, A. Ceccarelli, and F. Dubini The fecal microbial population in the irritable bowel syndrome Microbiologica 5 1982 185 194
87. E. Malinen, T. Rinttila, and K. Kajander Analysis of the fecal microbiota of irritable bowel syndrome patients and healthy controls with real-time PCR Am J Gastroenterol 100 2005 373 382
88. M. Simren, G. Barbara, and H.J. Flint Intestinal microbiota in functional bowel disorders: a Rome Foundation report Gut 62 2013 159 176
89. L. Crouzet, E. Gaultier, and C. Del'Homme The hypersensitivity to colonic distension of IBS patients can be transferred to rats through their fecal microbiota Neurogastroenterol Motil 25 2013 e272 e282
90. P.C. Kashyap, A. Marcobal, and L.K. Ursell Complex interactions among diet, gastrointestinal transit, and gut microbiota in humanized mice Gastroenterology 144 2013 967 977
91. S.M. Collins, M. Surette, and P. Bercik The interplay between the intestinal microbiota and the brain Nat Rev Microbiol 10 2012 735 742
92. M. Grover, M. Camilleri, and K. Smith On the fiftieth anniversary. Postinfectious irritable bowel syndrome: mechanisms related to pathogens Neurogastroenterol Motil 26 2014 156 167
93. P. Andrews, T.J. Borody, and N.P. Shortis Bacteriotherapy for chronic constipation - long term follow up (abstr) Gastroenterology 108 1995 A563
94. ClinicalTrials.gov. Fecal microbiota transplantation in HIV. Available at: https://clinicaltrials.gov/ct2/results?term=hiv+fmt&Search=Search. Accessed May 1, 2015.
95. Hamilton MJ, Weingarden AR, Sadowsky MJ, et al. Standardized frozen preparation for transplantation of fecal microbiota for recurrent Clostridium difficile infection. Am J Gastroenterol;107:761-767.
96. N.C. Patel, Cl Griesbach, and J.K. DiBaise Fecal microbiota transplant for recurrent Clostridium difficile infection: Mayo Clinic in Arizona experience Mayo Clin Proc 88 2013 799 805
97. R. Pathak, H.A. Enuh, and A. Patel Treatment of relapsing Clostridium difficile infection using fecal microbiota transplantation Clin Exp Gastroenterol 7 2014 1 6
98. F. Emanuelsson, B.E.B. Claesson, and L. Ljungström Faecal microbiota transplantation and bacteriotherapy for recurrent Clostridium difficile infection: a retrospective evaluation of 31 patients Scan J Infect Dis 46 2014 89 97
99. M. Schwartz, M. Gluck, and S. Koon Norovirus gastroenteritis after fecal microbiota transplantation for treatment of Clostridium difficile infection despite asymptomatic donors and lack of sick contacts Am J Gastroenterol 108 2013 1367
100. R. Quera, R. Espinoza, and C. Estay Bacteremia as an adverse event of fecal microbiota transplantation in a patient with Crohn's disease and recurrent Clostridium difficile infection J Crohns Colitis 8 2014 252 253
101. W.H. Tang, Z. Wang, and B.S. Levison Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk N Engl J Med 368 2013 1575 1584
102. Hurst M. DIY fecal transplants to cure yourself of ulcerative colitis. YouTube. June 4, 2013. Available at: https://www.youtube.com/watch?v=WEMnRC22oOs. Accessed May 1, 2015.
103. J.S. Zipursky, T.I. Sidorsky, and C.A. Freedman Physician attitudes toward the use of fecal microbiota transplantation for the treatment of recurrent Clostridium difficile infection Can J Gastroenterol Hepatol 28 2014 319 324
104. S.A. Kahn, A. Vachon, and D. Rodriquez Patient perceptions of fecal microbiota transplantation for ulcerative colitis Inflamm Bowel Dis 19 2013 1506 1513
105. L.J. Brandt Editorial commentary: fecal microbiota transplantation: patient and physician attitudes Clin Infect Dis 55 2012 1659 1660
106. C.R. Kelly, N. Okpara, L. deLeon, and D. Kertstetter Barriers to greater utilization of fecal bacteriotherapy for chronic Clostridium difficile infection (abstr) Am J Gastroenterol 105 2010 S135
107. S.A. Kahn, S. Young, and D.T. Rubin Colonoscopic fecal microbiota transplant for recurrent Clostridium difficile infection in a child Am J Gastroenterol 107 2012 1930 1931
108. G.H. Russell, J.L. Kaplan, and I. Youngster Fecal transplant for recurrent Clostridium difficile infection in children with and without inflammatory bowel disease J Pediatr Gastroenterol Nutr 58 2014 588 592
109. Y. Vandenplas, G. Veereman, and J. van der Werff Ten Bosch Fecal microbial transplantation in a one-year-old girl with early onset colitis - caution advised J Pediatr Gastroenterol Nutr 2014 Jan 2 [Epub ahead of print]
110. A. Pierog, A. Mencin, and N.R. Reilly Fecal microbiota transplantation in children with recurrent Clostridium difficile infection Pediatr Infect Dis J 33 2014 1198 1200
111. E. van Nood, P. Speelman, and M. Nieuwdorp Fecal microbiota transplantation: facts and controversies Curr Opin Gastroenterol 30 2014 34 39
112. E. Allen-Vercoe, G. Reid, and N. Viner A Canadian Working Group report on fecal microbial therapy: microbial ecosystems therapeutics Can J Gastroenterol 26 2012 457 462
113. US Food and Drug Adminstration. FDA drug definition. FDA Glossary of terms. Available at: http://www.fda.gov/drugs/informationondrugs/ucm079436.htm#D. Accessed May 1, 2015.
114. US Food and Drug Adminstration. Guidance for industry: enforcement policy regarding investigational new drug requirements for use of fecal microbiota for transplantation to treat Clostridium difficile infection not responsive to standard therapies. July 2013. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM361393.pdf. Accessed May 1, 2015.
115. C.R. Kelly, S.S. Kunde, and A. Khoruts Guidance on preparing an investigational new drug application for fecal microbiota transplantation studies Clin Gastroenterol Hepatol 12 2014 283 288
116. T. Moore, A. Rodriguez, and J.S. Bakken Fecal microbiota transplantation: a practical update for the infectious disease specialist Clin Infect Dis 58 2014 541 545
117. Khanna S, Pardi D, Kelly C, et al. Clinical evaluation of SER-109, a rationally designed, oral microbiome-based therapeutic for the treatment of recurrent Clostridium difficile. 2014.
118. E.O. Petrof, G.B. Gloor, and S.J. Vanner Stool substitute transplant therapy for the eradication of Clostridium difficile infection: 'RePOOPulating' the gut Microbiome 1 2013 3