MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation

Concerning the documentation of patients received fecal microbiota transplantation (FMT) due to Clostridium difficile associated diarrhea (CDAD), physicians from all German hospitals performing a FMT are invited to provide prospective and retrospective information on these cases. Documentation of patient is performed by using the web-based survey platform www.ClinicalSurveys.net which was set up by researchers of the University Hospital of Cologne. This survey platform enables an optimal performance in epidemiological, observational, and interventional trials and is characterized by layered access security and frequent data backup. It has been used for numerous registry and cohort studies with approval of competent authorities and ethics boards.

The following data items are retrospectively or prospectively documented into our database, depending on if a informed consent exists or not:

• Patient characteristics (age, gender, weight, height, underlying disease)
• Indication for FMT
• Administration of antibiotics, chemotherapy, and immunosuppression prior to FMT
• Bowel movement prior to FMT
• Screening prior to FMT
• Description concerning completion of FMT
• Basic informations of the donor
• Outcome
• Prospective long term follow up (10 days, four weeks, three months, six months, and 24 months)

The following two differences of data documentation are observed:

1. Retrospective data documentation: