Clinical trial NCT02681068: MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation
Official title: MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clostridium Infections
Keywords: Fecal microbiota transplantation (FMT)
Clostridium difficile associated diarrhea (CDAD)
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recurrent Clostridium difficile infection

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with Clostridium difficile associated diarrhea

Exclusion Criteria:

* Patients \< 18 years old

Primary outcomes:
measure: Number of participants without another Clostridium difficile infection after fecal microbiota transplantation (FMT)
timeFrame: 24 months after FMT
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 24 months after FMT
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
affiliation: University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany
name: Maria Vehreschild, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tacke D, Wisplinghoff H, Kretzschmar A, Farowski F, Koehler P, Herweg J, Cornely OA, Vehreschild MJ. First implementation of frozen, capsulized faecal microbiota transplantation for recurrent Clostridium difficile infection into clinical practice in Europe. Clin Microbiol Infect. 2015 Nov;21(11):e82-4. doi: 10.1016/j.cmi.2015.06.027. Epub 2015 Jul 8. No abstract available.
citation: Bestfater C, Vehreschild MJGT, Stallmach A, Tuffers K, Erhardt A, Frank T, Gluck T, Goeser F, Sellge G, Solbach P, Eisenlohr H, Storr M; German Clinical Microbiome Study Group (GCMSG). Clinical effectiveness of bidirectional fecal microbiota transfer in the treatment of recurrent Clostridioides difficile infections. Dig Liver Dis. 2021 Jun;53(6):706-711. doi: 10.1016/j.dld.2021.02.022. Epub 2021 Mar 18.
citation: Hagel S, Fischer A, Ehlermann P, Frank T, Tueffers K, Sturm A, Link A, Demir M, Siebenhaar A, Storr M, Glueck T, Siegel E, Solbach P, Goeser F, Koelbel CB, Lohse A, Luebbert C, Kandzi U, Maier M, Schuerle S, Lerch MM, Tacke D, Cornely OA, Stallmach A, Vehreschild M; German Clinical Microbiome Study Group (GCMSG). Fecal Microbiota Transplant in Patients With Recurrent Clostridium Difficile Infection. Dtsch Arztebl Int. 2016 Sep 5;113(35-36):583-9. doi: 10.3238/arztebl.2016.0583.