Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02681068
Recruitment Status : Unknown
Verified May 2017 by Maria J.G.T. Vehreschild, University of Cologne.
Recruitment status was:  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

Tracking Information
First Submitted Date February 2, 2016
First Posted Date February 12, 2016
Last Update Posted Date May 4, 2017
Study Start Date January 2015
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 9, 2016)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02681068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 9, 2016)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation
Official Title MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with recurrent Clostridium difficile infection
Condition Clostridium Infections
Intervention Other: Fecal microbiota transplantation (FMT)
Fecal microbiota transplantation (FMT) for patients with Clostridium difficile associated diarrhea
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 9, 2016)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with Clostridium difficile associated diarrhea

Exclusion Criteria:

  • Patients < 18 years old
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02681068
Other Study ID Numbers MicroTrans
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Maria J.G.T. Vehreschild, University of Cologne
Study Sponsor University of Cologne
Collaborators Not Provided
Investigators
Principal Investigator: Maria Vehreschild, MD University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany
PRS Account University of Cologne
Verification Date May 2017