Transpoosions Deemed Safe, Effective

Clostridium difficile infection (CDI) is the leading cause of health-care related diarrhea worldwide. Conservative treatment of CDI currently relies on the antibiotics metronidazole, vancomycin and fidaxomicin. Following treatment with these antibiotics, 9.0–26.9% of patients develop recurrent CDI (rCDI).

Fecal microbiota transplant (FMT) has been recognized as a feasible and effective procedure decades ago, however, the first randomized trial assessing the clinical efficacy of FMT by duodenal infusions, achieving sustained clinical cure in over 90% of patients with rCDI was not published until 2013. The success of this previously unpopular approach fueled various research efforts. In this context, other routes of application, i.e.

• gastric,
• colonic,
• rectal,
• or per capsule,

As well as improvement of FMT product storage using cryopreservation were assessed with favorable results. While most of these studies were observational, limited to one interventional treatment arm or to a small number of patients, a milestone randomized double-blind trial assessing the clinical efficacy of frozen as opposed to fresh FMT enemas in 232 adults was recently published and confirmed non-inferiority of frozen preparations. Inspired by the clinical impact of FMT and its rapid technical improvement, the interest of physicians in integrating FMT into their clinical armamentarium against rCDI is growing. In this setting, physicians are likely to encounter difficulties when searching for reliable standards with respect to donor screening, microbiota preparation, and route of administration. At the same time, colleagues considering referral of patients for FMT have difficulties identifying qualified centers.

To assess the current status of FMT in Germany with respect to active centers, local standard procedures, as well as clinical effectiveness and safety, we have created the MicroTrans Registry and herewith present results of its first dataset.