MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation

NCT ID: NCT02681068

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-12-31

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.

Conditions

Clostridium Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Fecal microbiota transplantation (FMT)

Fecal microbiota transplantation (FMT) for patients with Clostridium difficile associated diarrhea

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with Clostridium difficile associated diarrhea

Exclusion Criteria

• Patients < 18 years old

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Maria J.G.T. Vehreschild

PD Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Vehreschild, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany

Locations

University Hospital of Cologne

Cologne, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Maria Vehreschild, MD

Role: CONTACT

maria.vehreschild@uk-koeln.de

+49 221 478 88794

Stefan Hagel, MD

Role: CONTACT

stefan.hagel@med.uni-jena.de

+49 3641 9324590

Facility Contacts

Maria Vehreschild, MD

Role: primary

maria.vehreschild@uk-koeln.de

+49 221 478 88794

References

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.

Reference Type: RESULT

PMID: 26163107 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33744169 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27658471 (View on PubMed)

Other Identifiers

MicroTrans

Identifier Type: -

Identifier Source: org_study_id