Fäkaler Mikrobiota-Transfer (FMT) in Deutschland – Status und Perspektive

Zusammenfassung

Einführung Der Fäkale Mikrobiota-Transfer (FMT) ist eine Behandlung zur Modulation der gastrointestinalen Mikrobiota. Der Einsatz bei rezidivierender Clostridioides-difficile-Infektion (rCDI) ist europaweit etabliert und wird in nationalen und internationalen Leitlinien empfohlen. Der FMT ist in Deutschland im Fallpauschalensystem der Krankenhäuser kodierfähig. Eine auf dieser Kodierung basierende umfassende Erhebung zur Häufigkeit des Einsatzes fehlt bislang.

Material und Methodik Berichte des Instituts für das Entgeltsystem im Krankenhaus (InEK), des Statistischen Bundesamtes (DESTATIS) und Qualitätsberichte der Krankenhäuser 2015–2021 wurden auf FMT-Kodierung hin untersucht und im Rahmen einer strukturierten Expertenkonsultation bewertet.

Ergebnisse Zwischen 2015 und 2021 wurden von 175 Krankenhäusern 1.645 FMT-Verfahren kodiert. Von 2016 bis 2018 waren dies jährlich im Median 293 (274–313) FMT, gefolgt von einem konstanten Rückgang in den folgenden Jahren auf 119 FMT im Jahr 2021. Patienten/-innen mit FMT waren zu 57,7% weiblich, im Median 74 Jahre alt und der FMT wurde zu 72,2% koloskopisch appliziert. Bei 86,8 % der Fälle wurde eine CDI als Hauptdiagnose genannt, gefolgt von 7,6% eine Colitis ulcerosa.

Diskussion In Deutschland wird der FMT seltener eingesetzt als im europäischen Vergleich. Eine Anwendungshürde ist die behördliche Einordnung des FMT als nicht zugelassenes Arzneimittel, die zu erheblich höherem Aufwand bei Herstellung und Verabreichung führt und eine Erstattung erschwert. Die Europäische Kommission hat kürzlich eine Verordnung vorgeschlagen, den FMT als Transplantation einzuordnen. Dies könnte die regulatorische Situation des FMT in Deutschland perspektivisch verändern und so zu einem flächendeckenden Angebot eines in Leitlinien empfohlenen Therapieverfahrens beitragen.

Abstract

Introduction Fecal microbiota transfer (FMT) is a treatment to modulate the gastrointestinal microbiota. Its use in recurrent Clostridioides difficile infection (rCDI) is established throughout Europe and recommended in national and international guidelines. In Germany, the FMT is codeable in the hospital reimbursement system. A comprehensive survey on the frequency of use based on this coding is missing so far.

Material and methodology Reports of the Institute for Hospital Remuneration (InEK), the Federal Statistical Office (DESTATIS), and hospital quality reports 2015–2021 were examined for FMT coding and evaluated in a structured expert consultation.

Results Between 2015 and 2021, 1,645 FMT procedures were coded by 175 hospitals. From 2016 to 2018, this was a median of 293 (274–313) FMT annually, followed by a steady decline in subsequent years to 119 FMT in 2021. Patients with FMT were 57.7% female, median age 74 years, and FMT was applied colonoscopically in 72.2%. CDI was the primary diagnosis in 86.8% of cases, followed by ulcerative colitis in 7.6%.

Discussion In Germany, FMT is used less frequently than in the European comparison. One application hurdle is the regulatory classification of FMT as a non-approved drug, which leads to significantly higher costs in manufacturing and administration and makes reimbursement difficult. The European Commission recently proposed a regulation to classify FMT as a transplant. This could prospectively change the regulatory situation of FMT in Germany and thus contribute to a nationwide offer of a therapeutic procedure recommended in guidelines.

Schlüsselwörter

Clostridioides difficile - Fäkaler Mikrobiota-Transfer - Krankenhausdaten

Keywords

clostridioides difficile - fecal microbiota transfer - hospital data

Publication History

Received: 24 December 2022

Accepted after revision: 11 April 2023

Article published online:
15 May 2023

• Literatur

• 1 Allegretti JR, Mullish BH, Kelly C. et al. The evolution of the use of faecal microbiota transplantation and emerging therapeutic indications. The Lancet 2019; 394: 420-431 DOI: 10.1016/S0140-6736(19)31266-8. (PMID: 31379333)
• 2 Kriss M, Hazleton KZ, Nusbacher NM. et al. Low diversity gut microbiota dysbiosis: drivers, functional implications and recovery. Curr Opin Microbiol 2018; 44: 34-40 DOI: 10.1016/j.mib.2018.07.003. (PMID: 30036705)
• 3 Sokol H, Jegou S, McQuitty C. et al. Specificities of the intestinal microbiota in patients with inflammatory bowel disease and Clostridium difficile infection. Gut Microbes 2018; 9: 55-60 DOI: 10.1080/19490976.2017.1361092.
• 4 Cammarota G, Ianiro G, Kelly CR. et al. International consensus conference on stool banking for faecal microbiota transplantation in clinical practice. Gut 2019; 68: 2111-2121 DOI: 10.1136/gutjnl-2019-319548. (PMID: 31563878)
• 5 Cammarota G, Ianiro G, Tilg H. et al. European consensus conference on faecal microbiota transplantation in clinical practice. Gut 2017; 66: 569-580 DOI: 10.1136/gutjnl-2016-313017. (PMID: 28087657)
• 6 de Groot PF, Frissen MN, de Clercq NC. et al. Fecal microbiota transplantation in metabolic syndrome: History, present and future. Gut Microbes 2017; 8: 253-267 DOI: 10.1080/19490976.2017.1293224. (PMID: 28609252)
• 7 Eiseman B, Silen W, Bascom GS. et al. Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis. Surgery 1958; 44: 854-859 (PMID: 13592638)
• 8 Link A, Lachmund T, Schulz C. et al. Endoscopic peroral jejunal fecal microbiota transplantation. Digestive and Liver Disease 2016; 48: 1336-1339 DOI: 10.1016/j.dld.2016.08.110. (PMID: 27575658)
• 9 Kleger A, Schnell J, Essig A. et al. Fecal Transplant in Refractory Clostridium difficile Colitis. Dtsch Arztebl International 2013; 110: 108-115 DOI: 10.3238/arztebl.2013.0108. (PMID: 23468820)
• 10 Bestfater C, Vehreschild M, Stallmach A. et al. Clinical effectiveness of bidirectional fecal microbiota transfer in the treatment of recurrent Clostridioides difficile infections. Dig Liver Dis 2021; 53: 706-711 DOI: 10.1016/j.dld.2021.02.022. (PMID: 33744169)
• 11 Hagel S, Fischer A, Ehlermann P. et al. Fecal Microbiota Transplant in Patients With Recurrent Clostridium Difficile Infection. Dtsch Arztebl Int 2016; 113: 583-589 DOI: 10.3238/arztebl.2016.0583.
• 12 Peri R, Aguilar RC, Tüffers K. et al. The impact of technical and clinical factors on fecal microbiota transfer outcomes for the treatment of recurrent Clostridioides difficile infections in Germany. United European Gastroenterol J 2019; 7: 716-722 DOI: 10.1177/2050640619839918. (PMID: 31210950)
• 13 Alexander Link Entwicklung eines europäischen FMT Registers. Persönliche Mitteilung vom 08. August 2022.
• 14 van Nood E, Vrieze A, Nieuwdorp M. et al. Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile. New England Journal of Medicine 2013; 368: 407-415 DOI: 10.1056/NEJMoa1205037. (PMID: 23323867)
• 15 Hota SS, Sales V, Tomlinson G. et al. Oral Vancomycin Followed by Fecal Transplantation Versus Tapering Oral Vancomycin Treatment for Recurrent Clostridium difficile Infection: An Open-Label, Randomized Controlled Trial. Clin Infect Dis 2017; 64: 265-271 DOI: 10.1093/cid/ciw731. (PMID: 28011612)
• 16 Hvas CL, Dahl Jørgensen SM, Jørgensen SP. et al. Fecal Microbiota Transplantation Is Superior to Fidaxomicin for Treatment of Recurrent Clostridium difficile Infection. Gastroenterology 2019; 156: 1324-1332.e1323 DOI: 10.1053/j.gastro.2018.12.019.
• 17 Cammarota G, Masucci L, Ianiro G. et al. Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection. Alimentary Pharmacology & Therapeutics 2015; 41: 835-843 DOI: 10.1111/apt.13144. (PMID: 25728808)
• 18 Baunwall SMD, Andreasen SE, Hansen MM. et al. Faecal microbiota transplantation for first or second Clostridioides difficile infection (EarlyFMT): a randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol 2022; 7: 1083-1091 DOI: 10.1016/s2468-1253(22)00276-x. (PMID: 36152636)
• 19 Lee CH, Steiner T, Petrof EO. et al. 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: 142-149 DOI: 10.1001/jama.2015.18098.
• 20 Kassam Z, Lee CH, Yuan Y. et al. Fecal Microbiota Transplantation forClostridium difficileInfection: Systematic Review and Meta-Analysis. Official journal of the American College of Gastroenterology | ACG 2013; 108: 500-508 DOI: 10.1038/ajg.2013.59.
• 21 Cammarota G, Ianiro G, Gasbarrini A. Fecal Microbiota Transplantation for the Treatment of Clostridium difficile Infection: A Systematic Review. Journal of Clinical Gastroenterology 2014; 48: 693-702 DOI: 10.1097/mcg.0000000000000046. (PMID: 24440934)
• 22 Drekonkja D. Fecal Microbiota Transplantation for Clostridium difficile Infection. Annals of Internal Medicine 2015; 162: 630-638 DOI: 10.7326/m14-2693. (PMID: 25938992)
• 23 Mattila E, Uusitalo-Seppälä R, Wuorela M. et al. Fecal Transplantation, Through Colonoscopy, Is Effective Therapy for Recurrent Clostridium difficile Infection. Gastroenterology 2012; 142: 490-496 DOI: 10.1053/j.gastro.2011.11.037.
• 24 Tariq R, Pardi DS, Bartlett MG. et al. Low Cure Rates in Controlled Trials of Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection: A Systematic Review and Meta-analysis. Clinical Infectious Diseases 2018; 68: 1351-1358 DOI: 10.1093/cid/ciy721. (PMID: 30957161)
• 25 Li YT, Cai HF, Wang ZH. et al. Systematic review with meta-analysis: long-term outcomes of faecal microbiota transplantation for Clostridium difficile infection. Alimentary Pharmacology & Therapeutics 2016; 43: 445-457 DOI: 10.1111/apt.13492.
• 26 Dembrovszky F, Gede N, Szakács Z. et al. Fecal Microbiota Transplantation May Be the Best Option in Treating Multiple Clostridioides difficile Infection: A Network Meta-Analysis. Infect Dis Ther 2021; 10: 201-211 DOI: 10.1007/s40121-020-00356-9. (PMID: 33106983)
• 27 Song YN, Yang DY, Veldhuyzen van Zanten S. et al. Fecal Microbiota Transplantation for Severe or Fulminant Clostridioides difficile Infection: Systematic Review and Meta-analysis. J Can Assoc Gastroenterol 2022; 5: e1-e11 DOI: 10.1093/jcag/gwab023. (PMID: 35118227)
• 28 Singh T, Bedi P, Bumrah K. et al. Fecal Microbiota Transplantation and Medical Therapy for Clostridium difficile Infection: Meta-analysis of Randomized Controlled Trials. 2021; DOI: 10.1097/MCG.0000000000001610. (PMID: 34516460)
• 29 Baunwall SMD, Terveer EM, Dahlerup JF. et al. The use of Faecal Microbiota Transplantation (FMT) in Europe: A Europe-wide survey. Lancet Reg Health Eur 2021; 9: 100181 DOI: 10.1016/j.lanepe.2021.100181. (PMID: 34693388)
• 30 Surawicz CM, Brandt LJ, Binion DG. et al. Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections. Official journal of the American College of Gastroenterology (ACG) 2013; 108: 478-498 DOI: 10.1038/ajg.2013.4. (PMID: 23439232)
• 31 Debast SB, Bauer MP, Kuijper EJ. European Society of Clinical Microbiology and Infectious Diseases: Update of the Treatment Guidance Document for Clostridium difficile Infection. Clinical Microbiology and Infection 2014; 20: 1-26 DOI: 10.1111/1469-0691.12418. (PMID: 24118601)
• 32 Keller JJ, Ooijevaar RE, Hvas CL. et al. A standardised model for stool banking for faecal microbiota transplantation: a consensus report from a multidisciplinary UEG working group. United European Gastroenterology Journal 2021; 9: 229-247 DOI: 10.1177/2050640620967898.
• 33 Mullish BH, Quraishi MN, Segal JP. et al. The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridium difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines. Gut 2018; 67: 1920-1941 DOI: 10.1136/gutjnl-2018-316818. (PMID: 30154172)
• 34 Baunwall SMD, Dahlerup JF, Engberg JH. et al. Danish national guideline for the treatment of Clostridioides difficile infection and use of faecal microbiota transplantation (FMT). Scand J Gastroenterol 2021; 56: 1056-1077 DOI: 10.1080/00365521.2021.1922749. (PMID: 34261379)
• 35 Johnson S, Lavergne V, Skinner AM. et al. Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults. Clinical Infectious Diseases 2021; 73: e1029-e1044 DOI: 10.1093/cid/ciab549. (PMID: 34164674)
• 36 van Prehn J, Reigadas E, Vogelzang EH. et al. European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. Clinical Microbiology and Infection 2021; 27: S1-S21 DOI: 10.1016/j.cmi.2021.09.038. (PMID: 34678515)
• 37 Rossen NG, Fuentes S, van der Spek MJ. et al. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology 2015; 149: 110-118.e114 DOI: 10.1053/j.gastro.2015.03.045.
• 38 Moayyedi P, Surette MG, Kim PT. et al. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology 2015; 149: 102-109.e106 DOI: 10.1053/j.gastro.2015.04.001.
• 39 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: 913-916.e917 DOI: 10.1053/j.gastro.2012.06.031.
• 40 Ianiro G, Eusebi LH, Black CJ. et al. Systematic review with meta-analysis: efficacy of faecal microbiota transplantation for the treatment of irritable bowel syndrome. Alimentary Pharmacology & Therapeutics 2019; 50: 240-248 DOI: 10.1111/apt.15330.
• 41 Ghani R, Mullish BH, McDonald JAK. et al. Disease Prevention Not Decolonization: A Model for Fecal Microbiota Transplantation in Patients Colonized With Multidrug-resistant Organisms. Clinical Infectious Diseases 2020; 72: 1444-1447 DOI: 10.1093/cid/ciaa948.
• 42 Bajaj JS, Salzman NH, Acharya C. et al. Fecal Microbial Transplant Capsules Are Safe in Hepatic Encephalopathy: A Phase 1, Randomized, Placebo-Controlled Trial. Hepatology 2019; 70: 1690-1703 DOI: 10.1002/hep.30690. (PMID: 31038755)
• 43 Zoller V, Laguna AL, Prazeres Da Costa O. et al. Fecal microbiota transfer (FMT) in a patient with refractory irritable bowel syndrome. Dtsch Med Wochenschr 2015; 140: 1232-1236 DOI: 10.1055/s-0041-103798.
• 44 Verbeke F, Janssens Y, Wynendaele E. et al. Faecal microbiota transplantation: a regulatory hurdle?. BMC Gastroenterology 2017; 17: 128 DOI: 10.1186/s12876-017-0687-5. (PMID: 29179687)
• 45 Nawrat A. Exploring the challenges of regulating faecal microbiota transplants. Medical Device Network. 2021
• 46 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: 1079-1087 DOI: 10.1038/ajg.2012.60. (PMID: 22450732)
• 47 Paramsothy S, Borody TJ, Lin E. et al. Donor Recruitment for Fecal Microbiota Transplantation. Inflamm Bowel Dis 2015; 21: 1600-1606 DOI: 10.1097/mib.0000000000000405. (PMID: 26070003)
• 48 Stallmach A, Steube A, Grunert P. et al. Fecal Microbiota Transfer. Dtsch Arztebl Int 2020; 117: 31-38 DOI: 10.3238/arztebl.2020.0031. (PMID: 32031511)
• 49 Trubiano JA, Cheng AC, Korman TM. et al. Australasian Society of Infectious Diseases updated guidelines for the management of Clostridium difficile infection in adults and children in Australia and New Zealand. Internal Medicine Journal 2016; 46: 479-493 DOI: 10.1111/imj.13027. (PMID: 27062204)
• 50 Jiang Z-D, Hoang LN, Lasco TM. et al. Physician Attitudes Toward the Use of Fecal Transplantation for Recurrent Clostridium difficile Infection in a Metropolitan Area. Clinical Infectious Diseases 2013; 56: 1059-1060 DOI: 10.1093/cid/cis1025. (PMID: 23223589)
• 51 Zipursky JS, Sidorsky TI, Freedman CA. et al. Patient Attitudes Toward the Use of Fecal Microbiota Transplantation in the Treatment of Recurrent Clostridium difficile Infection. Clinical Infectious Diseases 2012; 55: 1652-1658 DOI: 10.1093/cid/cis809. (PMID: 22990849)
• 52 Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Fäkale Mikrobiota-Transplantation (FMT, Stuhltransplantation): Risiko für die Übertragung von multiresistenten Erregern vom 18. June 2019. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn. 2019 Accessed November 30, 2022 at: www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RI/2019/RI-FMT.html
• 53 Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Maßnahmen zur Minimierung des Risikos einer möglichen Übertragung von SARS-CoV-2 durch Fäkale Mikrobiota-Transplantation (FMT) vom 01.04.2020. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn. 2020 Accessed November 30, 2022 at: www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RI/2020/RI-FMT.html
• 54 Stallmach A, Steube A, Stallhofer J. et al. Fäkaler Mikrobiomtransfer – Indikationen, Risiken und Chancen. Die Innere Medizin 2022; 63: 1036-1042 DOI: 10.1007/s00108-022-01399-5.
• 55 Balsells E, Shi T, Leese C. et al. Global burden of Clostridium difficile infections: a systematic review and meta-analysis. J Glob Health 2019; 9: 010407 DOI: 10.7189/jogh.09.010407. (PMID: 30603078)
• 56 Guh AY, Mu Y, Winston LG. et al. Trends in U.S. Burden of Clostridioides difficile Infection and Outcomes. N Engl J Med 2020; 382: 1320-1330 DOI: 10.1056/NEJMoa1910215. (PMID: 32242357)
• 57 Lessa FC, Mu Y, Bamberg WM. et al. Burden of Clostridium difficile Infection in the United States. New England Journal of Medicine 2015; 372: 825-834 DOI: 10.1056/NEJMoa1408913. (PMID: 25714160)
• 58 Waye A, Atkins K, Kao D. Cost Averted With Timely Fecal Microbiota Transplantation in the Management of Recurrent Clostridium difficile Infection in Alberta, Canada. Journal of Clinical Gastroenterology 2016; 50: 747-753 DOI: 10.1097/mcg.0000000000000494. (PMID: 26890327)
• 59 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: 1507-1514 DOI: 10.1093/cid/ciu128. (PMID: 24692533)
• 60 Lapointe-Shaw L, Tran KL, Coyte PC. et al. Cost-Effectiveness Analysis of Six Strategies to Treat Recurrent Clostridium difficile Infection. PLOS ONE 2016; 11: e0149521 DOI: 10.1371/journal.pone.0149521. (PMID: 26901316)
• 61 Burton HE, Mitchell SA, Watt M. A Systematic Literature Review of Economic Evaluations of Antibiotic Treatments for Clostridium difficile Infection. Pharmacoeconomics 2017; 35: 1123-1140 DOI: 10.1007/s40273-017-0540-2. (PMID: 28875314)
• 62 Varier RU, Biltaji E, Smith KJ. et al. Cost-effectiveness analysis of treatment strategies for initial Clostridium difficile infection. Clin Microbiol Infect 2014; 20: 1343-1351 DOI: 10.1111/1469-0691.12805. (PMID: 25366338)
• 63 Deutsches Institut für Medizinische Dokumentation und Information (DIMDI). Operationen- und Prozedurenschlüssel Version 2015 vom 05.11.2014. Deutsches Institut für Medizinische Dokumentation und Information (DIMDI), Köln. 2015 Accessed November 30, 2022 at: www.dimdi.de/static/de/klassifikationen/ops/kode-suche/opshtml2015/
• 64 InEK GmbH – Institut für das Entgeltsystem im Krankenhaus. G-DRG-Browser 2019_2020 vom 17.03.2020. InEK GmbH – Institut für das Entgeltsystem im Krankenhaus, Siegburg. 2020 Accessed November 30, 2020 at: www.g-drg.de/datenbrowser-und-begleitforschung/g-drg-report-browser/ag-drg-report-browser-2020
• 65 Statistisches Bundesamt (DESTATIS). Operationen und Prozeduren der vollstationären Patientinnen und Patienten in Krankenhäusern (4-Steller) vom 30.11.2022. Statistisches Bundesamt (DESTATIS), Wiesbaden. 2022 Accessed November 30, 2022 at: www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Gesundheit/Krankenhaeuser/Publikationen/Downloads-Krankenhaeuser/operationen-prozeduren-5231401217014.html
• 66 Statistisches Bundesamt (DESTATIS). Gesundheitsberichterstattung des Bundes vom 30.11.2022. Statistisches Bundesamt (DESTATIS), Wiesbaden. 2022 Accessed November 30, 2022 at: www.destatis.de/DE/Home/_inhalt.html
• 67 Statistisches Bundesamt (DESTATIS) DRG-Statistik. In. Wiesbaden. 2022
• 68 InEK GmbH – Institut für das Entgeltsystem im Krankenhaus. Verfahrenseckpunkte für Anfragen nach § 6 Abs. 2 KHEntgG (Neue Untersuchungs- und Behandlungsmethoden) vom 01.09.2022. InEK GmbH – Institut für das Entgeltsystem im Krankenhaus, Siegburg. 2022 Accessed November 30, 2022 at: www.g-drg.de/neue-untersuchungs-und-behandlungsmethoden-nub/drg/verfahrenseckpunkte
• 69 InEK GmbH – Institut für das Entgeltsystem im Krankenhaus. Aufstellung der Informationen nach § 6 Abs. 2 KHEntgG für 2022 vom 31.01.2022. InEK GmbH – Institut für das Entgeltsystem im Krankenhaus, Siegburg. 2022 Accessed November 30, 2022 at: www.g-drg.de/ag-drg-system-2022/neue-untersuchungs-und-behandlungsmethoden-nub/aufstellung-der-informationen-nach-6-abs.-2-khentgg-fuer-2022
• 70 Christian Jacobs: Was fehlt der FMT? Persönliche Mitteilung vom 14.09.2022.
• 71 Deutsches Institut für Medizinische Dokumentation und Information (DIMDI) Änderungsvorschlag für den OPS 2015: Stuhltransplanation vom 28.02.2014. Deutsches Institut für Medizinische Dokumentation und Information (DIMDI), Köln. 2014 Accessed November 30, 2022 at: www.multimedia.gsb.bund.de/BfArM/downloads/klassifikationen/ops/vorschlaege/vorschlaege2015/309-stuhltransplantation-schepp.pdf
• 72 König J, Siebenhaar A, Högenauer C. et al. Consensus report: faecal microbiota transfer – clinical applications and procedures. Alimentary Pharmacology & Therapeutics 2017; 45: 222-239 DOI: 10.1111/apt.13868. (PMID: 27891639)
• 73 National Institute for Health and Care Excellence (NICE). Faecal microbiota transplant for recurrent Clostridium difficile infection vom 27.03.2014. National Institute for Health and Care Excellence (NICE), London. 2014 Accessed November 30, 2022 at: www.nice.org.uk/guidance/ipg485/
• 74 National Institute for Health and Care Excellence (NICE). Faecal microbiota transplant for recurrent Clostridioides difficile infection vom 31.08.2022. National Institute for Health and Care Excellence (NICE), London. 2022 Accessed November 30, 2022 at: www.nice.org.uk/guidance/mtg71
• 75 National Institute for Health and Care Excellence (NICE). Medical technology consultation: GID-MT566 Faecal microbiota transplant for recurrent Clostridioides difficile infection vom 11.05.2022. National Institute for Health and Care Excellence (NICE), London. 2022 Accessed November 30, 2022 at: www.nice.org.uk/guidance/mtg71/documents/supporting-documentation
• 76 Lübbert C, Lippmann N, von Braun A. New Guidelines and Data to Clostridium difficile – What's New?. Dtsch Med Wochenschr 2018; 143: 787-792 DOI: 10.1055/a-0585-9595. (PMID: 29807377)
• 77 Liebhardt E ST, Wagner M. Stuhltransplantation bei Clostridium difficile-Infektionen. Arzneimitteltherapie 2016; 34: 285-291
• 78 European Medicines Agency (EMA). Faecal Microbiota Transplantation EU-IN Horizon Scanning Report vom Juni 2022. European Medicines Agency (EMA), Amsterdam, 2022. Accessed November 30, 2022 at: www.ema.europa.eu/en/documents/report/faecal-microbiota-transplantation-eu-horizon-scanning-report_en.pdf
• 79 European Commission. Proposal of a regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC vom 14.07.2022. European Commission, Brussels. 2022 Accessed November 30, 2022 at: www.eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=COM:2022:338:FIN&from=EN
• 80 Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). OPS Version 2022 vom 26.10.2021. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn . 2022 Accessed November 30, 2022 at: https://www.dimdi.de/static/de/klassifikationen/ops/kode-suche/opshtml2022/