MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation (MicroTrans)

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.

Study Overview

• Status: Unknown
• Conditions: Clostridium Infections
• Intervention / Treatment: Other: Fecal microbiota transplantation (FMT)

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Maria Vehreschild, MD; Phone Number: +49 221 478 88794; Email: maria.vehreschild@uk-koeln.de
• Study Contact Backup: Name: Stefan Hagel, MD; Phone Number: +49 3641 9324590; Email: stefan.hagel@med.uni-jena.de

Study Locations

• Germany
  • Cologne, Germany, 50937
    • Recruiting
    • University Hospital of Cologne
    • Contact: Maria Vehreschild, MD; Phone Number: +49 221 478 88794; Email: maria.vehreschild@uk-koeln.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent Clostridium difficile infection

Description

Inclusion Criteria:

• Patients with Clostridium difficile associated diarrhea

Exclusion Criteria:

• Patients < 18 years old

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants without another Clostridium difficile infection after fecal microbiota transplantation (FMT)	A 24 month follow-up allows analyses of long-term effects of FMT	24 months after FMT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	A 24 month follow-up allows analyses of long-term effects of FMT	24 months after FMT

Collaborators and Investigators

• Sponsor: University of Cologne
• Investigators: Principal Investigator: Maria Vehreschild, MD, University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Website study group

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 9, 2016
• First Posted (Estimate): February 12, 2016

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Fecal microbiota transplantation (FMT); Clostridium difficile associated diarrhea (CDAD)
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections
• Other Study ID Numbers: MicroTrans

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No