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

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 *

• 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.
• 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.

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

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