MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation
MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation
The registry collects cases of patients received fecal microbiota transplantation (FMT) due
 to Clostridium difficile associated diarrhea (CDAD). The main objective of this study is to
 analyze the safety and effectiveness of FMT. Furthermore, data analysis will be used to
 implement a standardization of FMT in German hospitals and improve patient outcome.
 Therefore, a detailed description of completions of FMT are documented on our web-based
 survey platform www.ClinicalSurveys.net.
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:

 Data of patients without an informed consent are documented strictly retrospectively
 after completion of the FMT. No pseudonymization of patient data is carried out so that
 no re-identification is possible.

 2. Prospective data documentation:

 Data of patients with an informed consent prior to FMT are documented prospectively. A
 pseudonymization of patient data allows a post-FMT contact (by writing or phone) to patients
 with respect to the 10 days, four weeks, three months, six months,and 24 months follow-up.
Inclusion Criteria:

 -  Patients with Clostridium difficile associated diarrhea

 Exclusion Criteria:

 -  Patients < 18 years old