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

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

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement


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


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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681068


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

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
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:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections