Biotechnologia Acta


  • Increase font size
  • Default font size
  • Decrease font size
Print PDF

ISSN 2410-7751 (Print)
ISSN 2410-776X (Online)

Ж-л "Biotechnologia Acta" Т. 14, № 1 , 2021
С. 46-56, библиогр. 61, англ.
УДК: 579.61 + 616.34-008.87


Bakalchuk M. M., Besarab O. B.

National Technical University of Ukraine “Igor Sikorsky Kyiv Polytechnic Institute”

Fecal microbiota transplantation (FMT) is a treatment method based on donor's fecal solution injection into the patient's gastrointestinal tract. FMT is effectively used in the treatment of recurrent Clostridium difficile infection. There is also growing interest in the therapeutic application of the method to treat metabolic, autoimmune and other disorders that was not previously associated with intestinal microbiota. Despite the promising results of FMT use, the organizational and legal matters and that of the safety FMT application have not yet been resolved in the European and Ukrainian medical community. The purpose of this review was to summarize information on the FMT application and the regulatory aspects of its use. The analysis of the practical instructions provisions of for FMT applying in clinical practice was carried out, and the bioethical problems associated with the FMT use were investigated.

Key words: intestinal microbiota, fecal microbiota transplantation, Clostridium difficile, inflammatory bowel disorder.

© Palladin Institute of Biochemistry of National Academy of Sciences of Ukraine, 2021

  • References
    • 1. Neish A. S. Microbes in gastrointestinal health and disease. Gastroenterology. 2009, 136(1), 65–80.

      2. Evdokimova N.V., Chernen’kaja T.V. Fecal Microbiota Transplantation: Past, Present and Future. Zhurnal im. N.V. Sklifosovskogo Neotlozhnaya medicinskaya pomoshch. 2019, 8(2), 160–165. (In Russian).

      3. Clemente J. C., Manasson J., Scher J. U. The role of the gut microbiome in systemic inflammatory disease. BMJ (Clinical research ed.). 2018, 360.

      4. Mohajeri M. H., Brummer R., Rastall R. A., Weersma R. K., Harmsen H., Faas M., Eggersdorfer M. The role of the microbiome for human health: from basic science to clinical applications. European journal of nutrition. 2018, 57(Suppl 1), 1–14.

      5. Tseng CH, Wu CY. The gut microbiome in obesity. J Formos Med Assoc. 2019, 118 Suppl 1:S3-S9.

      6. Vasil’ev A. N., Gorjachev D. V., Gavrishina E. V., Nijazov R. R., Seliverstov Ju. A., & Digtjar’ A. V. Fecal microbiota transplantation: possible therapeutic approaches and regulatory issues. Biopreparaty. Profilaktika, diagnostika, lechenie. 2015, 2 (54), 15-23. (In Russian).

      7. Wang S., Xu M., Wang W., Cao X., Piao M., Khan S., Yan F., Cao H., Wang B. Systematic Review: Adverse Events of Fecal Microbiota Transplantation. PLoS One. 2016, 11(8).

      8. de Groot P.F., Frissen M. N., de Clercq N. C., Nieuwdorp M. Fecal microbiota transplantation in metabolic syndrome: History, present and future. Gut Microbes. 2017, 8(3), 253-267.

      9. Rubin T. A., Gessert C. E., Aas J., Bakken J. S. Fecal microbiome transplantation for recurrent Clostridium difficile infection: report on a case series. Anaerobe. 2013, 19, 22–26.

      10. Kelly B. J., Tebas P. Clinical Practice and Infrastructure Review of Fecal Microbiota Transplantation for Clostridium difficile Infection. Chest. 2018, 153(1), 266–277.

      11. Czepiel J., Dr??d? M., Pituch H., Kuijper E. J., Perucki W., Mielimonka A., Goldman S., Wulta?ska D., Garlicki A., Biesiada G. Clostridium difficile infection: review. European journal of clinical microbiology & infectious diseases: official publication of the European Society of Clinical Microbiology. 2019, 38(7), 1211–1221.

      12. Hubska O. Yu., Hridniev O. Ye. . Fecal microbiota transplantation: a modern, effective and safe method of treating Clostridium difficile infection. Suchasna Hastroenterolohiia. 2019, 3, 66–78. (In Ukrainian).

      13. Cammarota G., Ianiro G., Tilg H., et al. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017, 66(4), 569-580.

      14. Tang G., Yin W., Liu W. Is frozen fecal microbiota transplantation as effective as fresh fecal microbiota transplantation in patients with recurrent or refractory Clostridium difficile infection: A metaanalysis? Diagn Microbiol Infect Dis. 2017, 88(4), 322-329.

      15. Lee C. H., Steiner T., Petrof E. O., Smieja M., Roscoe D., Nematallah A., Weese J. S., Collins S., Moayyedi P., Crowther M., Ropeleski M. J., Jayaratne P., Higgins D., Li Y., Rau N. V., Kim P. T. Frozen vs Fresh Fecal Microbiota Transplantation and Clinical Resolution of Diarrhea in Patients With Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2016, 315(2), 142-149.

      16. Gough E., Shaikh H., Manges A.R. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011, 53(10), 994-1002.

      17. Vindigni S.M, Surawicz C.M. Fecal Microbiota Transplantation. Gastroenterol. Clin. North. Am. 2017, 46(1), 171-185.

      18. Mattila E., Uusitalo-Sepp?l? R., Wuorela M., Lehtola L., Nurmi H., Ristikankare M., Moilanen V., Salminen K., Sepp?l? M., Mattila P. S., Anttila V. J., Arkkila P. Fecal transplantation, through colonoscopy, is effective therapy for recurrent Clostridium difficile infection. Gastroenterology. 2012, 142(3), 490–496.

      19. Kelly C. R., de Leon L., Jasutkar N. Fecal microbiota transplantation for relapsing Clostridium difficile infection in 26 patients: methodology and results. Journal of clinical gastroenterology. 2012, 46(2), 145–149.

      20. Yoon S. S., Brandt L. J. Treatment of refractory/recurrent C. difficile-associated disease by donated stool transplanted via colonoscopy: a case series of 12 patients. Journal of clinical gastroenterology. 2010, 44(8), 562–566.

      21. Kassam Z., Hundal R., Marshall J. K., Lee C. H. Fecal transplant via retention enema for refractory or recurrent Clostridium difficile infection. Arch. Intern. Med. 2012, 172(2), 191–193.

      22. Gweon T. G., Kim J., Lim C. H., Park J. M., Lee D. G., Lee I. S., Cho Y. S., Kim S. W., Choi M. G. Fecal Microbiota Transplantation Using Upper Gastrointestinal Tract for the Treatment of Refractory or Severe Complicated Clostridium difficile Infection in Elderly Patients in Poor Medical Condition: The First Study in an Asian Country. Gastroenterology research and practice. 2016.

      23. Kao D., Roach B., Silva M., Beck P., Rioux K., Kaplan G. G., Chang H. J., Coward S., Goodman K. J., Xu H., Madsen K., Mason A., Wong G. K., Jovel J., Patterson J., Louie T. Effect of Oral Capsule- vs ColonoscopyDelivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2017, 318(20), 1985–1993.

      24. Smits L. P., Bouter K. E., de Vos W. M., Borody T. J., Nieuwdorp M. Therapeutic potential of fecal microbiota transplantation. Gastroenterology. 2013 Nov, 145(5), 946-53.

      25. Kassam Z., Lee C. H., Yuan Y., Hunt R. H. Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. The American journal of gastroenterology. 2013, 108(4), 500–508.

      26. Agrawal M., Aroniadis O. C., Brandt L. J., Kelly C., Freeman S., Surawicz C., Broussard E., Stollman N., Giovanelli A., Smith B., Yen E., Trivedi A., Hubble L., Kao D., Borody T., Finlayson S., Ray A., Smith R. The Longterm Efficacy and Safety of Fecal Microbiota Transplant for Recurrent, Severe, and Complicated Clostridium difficile Infection in 146 Elderly Individuals. Journal of clinical gastroenterology. 2016, 50(5), 403–407.

      27. Girotra M., Garg S., Anand R., Song Y., Dutta S. K. Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection in the Elderly: Long-Term Outcomes and Microbiota Changes. Digestive diseases and sciences. 2016, 61(10), 3007–3015.

      28. Khoruts A., Rank K. M., Newman K. M., Viskocil K., Vaughn B. P., Hamilton M. J., Sadowsky M. J. Inflammatory Bowel Disease Affects the Outcome of Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2016, 14(10), 1433–1438.

      29. Van Nood E., Vrieze A., Nieuwdorp M., Fuentes S., Zoetendal E. G., de Vos W. M., Visser C. E., Kuijper E. J., Bartelsman J. F., Tijssen J. G., Speelman P., Dijkgraaf M. G., Keller J. J. Duodenal infusion of donor feces for recurrent Clostridium difficile. N. Engl. J. Med. 2013 Jan 31, 368(5), 407-15.

      30. Borody T. J., Brandt L. J., Paramsothy S. T h e r a p e u t i c f a e c a l m i c r o b i o t a transplantation: current status and future developments. Curr Opin Gastroenterol. 2014, 30(1), 97-105.

      31. Uygun A., Ozturk K., Demirci H., Oger C., Avci I. Y., Turker T., Gulsen M. Fecal microbiota transplantation is a rescue treatment modality for refractory ulcerative colitis. Medicine. 2017, 96(16).

      32. Borody T., Wettstein A., Campbell J. et al. Fecal microbiota transplantation in ulcerative colitis: review of 24 years experience [abstract]. Am. J. Gastroenterol. 2012, 107.

      33. Vermeire S., Joossens M., Verbeke K. et al. Pilot study on the safety and efficacy of fecal microbiota transplantation in refractory Crohn’s disease. Gastroenterology. 2012, 142, 360.

      34. Green J. E., Davis J. A., Berk M., Hair C., Loughman A., Castle D., Athan E., Nierenberg A. A., Cryan J. F., Jacka F., Marx W. Efficacy and safety of fecal microbiota transplantation for the treatment of diseases other than Clostridium difficile infection: a systematic review and meta-analysis. Gut microbes. 2020, 12(1), 1–25.

      35. Johnsen P. H., Hilp?sch F., Cavanagh J. P., Leikanger I. S., Kolstad C., Valle P. C., Goll R. Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, singlecentre trial. The lancet. Gastroenterol. hepatol. 2018, 3(1), 17–24.

      36. Ianiro G., Eusebi L. H., Black C. J., Gasbarrini A., Cammarota G., Ford A. C. Systematic review with meta-analysis: efficacy of faecal microbiota transplantation for the treatment of irritable bowel syndrome. Alimentary Pharmacology & Therapeutics. 2019, 50(3), 240–248.

      37. Pinn D. M., Aroniadis O. C., Brandt L. J. Follow-up study of fecal microbiota transplantation (FMT) for the treatment of refractory irritable bowel syndrome (IBS) [abstract]. ACG 2013 Annual Scientific Meeting and Postgraduate Course; 11–16 October 2013 San Diego, CA: San Diego Convention Center.

      38. Halkj?r S. I., Christensen A. H., Lo B., Browne P. D., G?nther S., Hansen L. H., Petersen A. M. Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study. Gut. 2018, 67(12), 2107–2115.

      39. Chen F., Stappenbeck T. S. Microbiome control of innate reactivity. Current opinion in immunology. 2019, 56, 107–113.

      40. McCoy K. D., Ignacio A., Geuking M. B. Microbiota and Type 2 immune responses. Current opinion in immunology. 2019, 54, 20–27.

      41. Xu M. Q., Cao H. L., Wang W. Q., Wang S., Cao X. C., Yan F., Wang B. M. Fecal microbiota transplantation broadening its application beyond intestinal disorders. World journal of gastroenterology. 2015, 21(1), 102–111.

      42. Borody T. J., Campbell J., Torres M. et al. Reversal of idiopathic thrombocytopenic purpura (ITP) with fecal microbiota transplantation (FMT) [abstract]. Am J Gastroenterol. 2011, 106, 352.

      43. Borody T. J., Leis S. M., Campbell J., Torres M., Nowak A. Fecal microbiota transplantation (FMT) in multiple sclerosis (MS). Am J Gastroenterol. 2011, 106, 352.

      44. Ridaura V. K., Faith J. J., Rey F. E., Cheng J., Duncan A. E., Kau A. L., Griffin N. W., Lombard V., Henrissat B., Bain J. R., Muehlbauer M. J., Ilkayeva O., Semenkovich C. F., Funai K., Hayashi D. K., Lyle B. J., Martini M. C., Ursell L. K., Clemente J. C., Van Treuren W., Gordon J. I. Gut microbiota from twins discordant for obesity modulate metabolism in mice. Science. 2013, 341(6150).

      45. Vrieze A., Van Nood E., Holleman F., Saloj?rvi J., Kootte R. S., Bartelsman J. F., Dallinga-Thie G. M., Ackermans M. T., Serlie M. J., Oozeer R., Derrien M., Druesne A., Van Hylckama Vlieg J. E., Bloks V. W., Groen A. K., Heilig H. G., Zoetendal E. G., Stroes E. S., de Vos W. M., Hoekstra J. B., Nieuwdorp M. Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome. Gastroenterology. 2012, 143(4), 913–6.e7.

      46. Fischer M., Sipe B., Torbeck M., Xu H., Kassam Z., Allegretti J. R. Does fecal microbiota transplantation from an obese donor lead to weight gain? a case series of 70 recipients. Gastroenterology. 2017, 152(5), p. S1004.

      47. Kang D. W., Adams J. B., Gregory A. C., Borody T., Chittick L., Fasano A., Khoruts A., Geis E., Maldonado J., McDonough-Means S., Pollard E. L., Roux S., Sadowsky M. J., Lipson K. S., Sullivan M. B., Caporaso J. G., Krajmalnik-Brown R. Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study. Microbiome. 2017, 5(1), 10.

      48. Mole B. FDA gets to grips with faeces. Nature. 2013, 498(7453), 147–148.

      49. De Vrieze J. Medical research. The promise of poop. Science (New York, N.Y.). 2013, 341(6149), 954–957.

      50. U.S. Food and Drug Administration: FDA’s Public Workshop; Fecal Microbiota for Transplantation — Presentations. Available at: BiologicsBloodVaccines/NewsEvents/ WorkshopsMeetingsConferences/ ucm352636.htm (accessed 20 January 2021).

      51. Roldan G. A., Cui A. X., Pollock N. R. Assessing the Burden of Clostridium difficile Infection in Low- and Middle-Income Countries. Journal of clinical microbiology. 2018, 56(3), e01747-17.

      52. Zhang S., Palazuelos-Munoz S., Balsells E. M., Nair H., Chit A., Kyaw M. H. Cost of hospital management of Clostridium difficile infection in United States-a meta-analysis and modelling study. BMC infectious diseases. 2016, 16(1), 447.

      53. Reigadas Ram?rez E., Bouza E. S. Economic Burden of Clostridium difficile Infection in European Countries. Advances in experimental medicine and biology. 2 0 1 8 , 1 0 5 0 , 1 – 1 2 . h t t p s : / / d o i . org/10.1007/978-3-319-72799-8_1.

      54. Konijeti G. G., Sauk J., Shrime M. G., Gupta M., Ananthakrishnan A. N. Costeffectiveness of competing strategies for management of recurrent Clostridium difficile infection: a decision analysis. Clin. Infect. Dis. 2014 Jun, 58(11), 1507-14.

      55. Lapointe-Shaw L., Tran K. L., Coyte P. C., Hancock-Howard R. L., Powis J., Poutanen S. M., Hota S. Cost-Effectiveness Analysis of Six Strategies to Treat Recurrent Clostridium difficile Infection. PLoS One. 2016 Feb 22, 11(2).

      56. Zainab I. Abdali, Tracy E. Roberts, Pelham Barton, Peter M. Hawkey. Economic evaluation of Faecal microbiota transplantation compared to antibiotics for the treatment of recurrent Clostridioides difficile infection. EClinicalMedicine. 2020.

      57. Ma Yonghui, Liu Jiayu, Rhodes Catherine, Nie Yongzhan, Zhang Faming. Ethical Issues in Fecal Microbiota Transplantation in Practice. The American Journal of Bioethics. 2017, 17, 34-45. 265161.2017.1299240.

      58. Zoya Grigoryan, Michael J. Shen, Shaina W. Twardus, Marc M. Beuttler, Lea Ann Chen, Alison Bateman-House. Fecal microbiota transplantation: Uses, questions, and ethics. Medicine in Microecology. 2020, 6.

      59. Bokulich N. A., Chung J., Battaglia T., Henderson N., Jay M., Li H., D Lieber A., Wu F., Perez-Perez G. I., Chen Y., Schweizer W., Zheng X., Contreras M., Dominguez-Bello M. G., Blaser M. J. Antibiotics, birth mode, and diet shape microbiome maturation during early life. Science translational medicine. 2016, 8(343), 343ra82.

      60. Fujimura K. E., Sitarik A. R., Havstad S., Lin D. L., Levan S., Fadrosh D., Panzer A. R., LaMere B., Rackaityte E., Lukacs N. W., Wegienka G., Boushey H. A., Ownby D. R., Zoratti E. M., Levin A. M., Johnson C. C., Lynch S. V. Neonatal gut microbiota associates with childhood multisensitized atopy and T cell differentiation. Nature medicine. 2016, 22(10), 1187–1191.

      61. Zhang F., Zhang T., Zhu H., Borody T. J. Evolution of fecal microbiota transplantation in methodology and ethical issues. Current opinion in pharmacology. 2019, 49, 11–16.


Additional menu

Site search

Site navigation


Invitation to cooperation

Dear colleagues, we invite you to publish your articles in our journal.
© Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine, 2008.
All rights are reserved. Complete or partial reprint of the journal is possible only with the written permission of the publisher.
for information: