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

• ClinicalTrials.gov Identifier: NCT02681068
• Recruitment Status: Unknown
• First Posted: February 12, 2016
• Last Update Posted: May 4, 2017
• Sponsor: University of Cologne
• Information provided by (Responsible Party): Maria J.G.T. Vehreschild, University of Cologne

Study Description

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.

Condition or disease	Intervention/treatment
Clostridium Infections	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 Design

• Study Type: Observational
• Estimated Enrollment: 1000 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation
• Study Start Date: January 2015
• Estimated Primary Completion Date: March 2019
• Estimated Study Completion Date: December 2019

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

1. Number of participants without another Clostridium difficile infection after fecal microbiota transplantation (FMT) [ Time Frame: 24 months after FMT ]
   A 24 month follow-up allows analyses of long-term effects of FMT

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent Clostridium difficile infection

Criteria

Inclusion Criteria:

• Patients with Clostridium difficile associated diarrhea

Exclusion Criteria:

• Patients < 18 years old

Contacts and Locations

Contacts

Contact: Maria Vehreschild, MD; +49 221 478 88794; maria.vehreschild@uk-koeln.de

Contact: Stefan Hagel, MD; +49 3641 9324590; stefan.hagel@med.uni-jena.de

Locations

Germany

University Hospital of Cologne; Recruiting

Cologne, Germany, 50937

Contact: Maria Vehreschild, MD +49 221 478 88794 maria.vehreschild@uk-koeln.de

Sponsors and Collaborators

University of Cologne

Investigators

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

More Information

Additional Information:

Website study group 

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Maria J.G.T. Vehreschild, PD Dr. med., University of Cologne
• ClinicalTrials.gov Identifier: NCT02681068 History of Changes
• Other Study ID Numbers: MicroTrans
• First Posted: February 12, 2016
• Last Update Posted: May 4, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Maria J.G.T. Vehreschild, University of Cologne:

Fecal microbiota transplantation (FMT); Clostridium difficile associated diarrhea (CDAD)

Additional relevant MeSH terms:

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections