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Multicenter Study Observational Study
Fecal Microbiota Transplant in Patients With Recurrent Clostridium Difficile Infection.
- Stefan Hagel, Anne Fischer, Philipp Ehlermann, Thorsten Frank, Kester Tueffers, Andreas Sturm, Alexander Link, Muenevver Demir, Arno Siebenhaar, Martin Storr, Thomas Glueck, Erhard Siegel, Philip Solbach, Felix Goeser, Christian B. Koelbel, Ansgar Lohse, Christoph Luebbert, Ulrich Kandzi, Matthias Maier, Stefanie Schuerle, Markus M. Lerch, Daniela Tacke, Oliver A. Cornely, Andreas Stallmach, Maria Vehreschild, and German Clinical Microbiome Study Group (GCMSG).
- Center for Infectious Diseases and Infection Control, Jena University Hospital
- Dtsch Arztebl Int. 2016 Sep 5; 113 (35-36): 583-9.
BackgroundThe clinical effectiveness of fecal microbiota transplant (FMT) for the treatment of recurrent Clostridium difficile infections (rCDI) has been demonstrated in randomized controlled trials. To assess the current status of FMT in Germany with respect to active centers, local standards, clinical effectiveness and safety, the MicroTrans Registry (NCT02681068) was established.MethodsIn a long-term retrospective multicenter observational study by the German Clinical Microbiome Study Group (GCMSG), primary and secondary cure on day 30 and 90, as well as occurrence of treatment-related adverse events were assessed. In addition to patient demographic data, we provide an overview of the FMT procedures and techniques used at different centers.ResultsOverall, 133 eligible patients from 33 centers were included, of which 64.7% were female (n = 86). The mean age was 75 years (interquartile range: 59.5-81.5). Administration via the duodenal route (n = 59; 44.4%) was the most frequently applied option, followed by colonic (n = 55; 41.1%), capsule (n = 13; 9.8%), and gastric administration (n = 4; 3.0%). Primary cure on day 30 and 90 was achieved in 84.2% (n = 101/120) and 78.3% (n = 72/92) of patients, respectively. Including re-treatment, secondary response was achieved in 87.5% (d 30; n = 105/120) and 85.9% (d 90; n = 79/92), respectively. Treatment- elated adverse events were documented in 16 patients (12.0%).ConclusionFMT is a safe and effective treatment option for rCDI. However, FMT is currently available only in few centers in Germany, and treatment options vary from one center to another.
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