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Related Experiment Video

Updated: Jul 30, 2025

Therapeutic Evaluation of Fecal Microbiota Transplantation in an Interleukin 10-Deficient Mouse Model
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[Fecal Microbiota Transfer (FMT) in Germany - Status and Perspective].

Andreas Stallmach1, Lutz von Müller2, Martin Storr3

  • 1Klinik für Innere Medizin IV, Universitätsklinikum Jena, Jena, Deutschland.

Zeitschrift Fur Gastroenterologie
|May 15, 2023
PubMed
Summary

Fecal microbiota transfer (FMT) use in Germany declined from 2016-2021, with regulatory hurdles impacting its accessibility. Reclassification as a transplant could improve FMT availability for conditions like recurrent Clostridioides difficile infection.

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Area of Science:

  • Gastroenterology and Hepatology
  • Microbiome Research
  • Health Services Research

Context:

  • Fecal microbiota transfer (FMT) is an established treatment for recurrent Clostridioides difficile infection (rCDI) in Europe, with coding available in Germany's hospital system.
  • Despite guideline recommendations, comprehensive data on FMT utilization in Germany was lacking.
  • This study analyzes FMT coding data from 2015-2021 to assess its frequency and application in German hospitals.

Purpose:

  • To quantify the frequency of FMT procedures in Germany between 2015 and 2021.
  • To identify patient demographics and primary diagnoses associated with FMT application.
  • To explore barriers to FMT use and potential regulatory solutions.

Summary:

  • A total of 1,645 FMT procedures were recorded across 175 German hospitals from 2015 to 2021.
  • Annual FMT use peaked between 2016-2018 and subsequently declined, with 119 procedures in 2021.
  • The majority of patients were female (57.7%), with a median age of 74; 86.8% of cases involved Clostridioides difficile infection (CDI), and 72.2% of FMTs were administered colonoscopically.

Impact:

  • FMT use in Germany is lower compared to European benchmarks.
  • Regulatory classification of FMT as a non-approved drug presents a significant barrier, increasing costs and complicating reimbursement.
  • A proposed EU regulation to classify FMT as a transplant could improve its regulatory status and facilitate wider access to this guideline-recommended therapy in Germany.