MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation

Clostridium Infections Clinical Trial

— MicroTrans  

Official title:

MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02681068
• Other study ID #: MicroTrans
• Status: Recruiting
• Phase: N/A
• First received: February 2, 2016
• Last updated: May 3, 2017
• Start date: January 2015
• Est. completion date: December 2019

Study information

• Verified date: May 2017
• Source: University of Cologne
• Contact: Maria Vehreschild, MD
• Phone: +49 221 478 88794
• Email: maria.vehreschild[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients with Clostridium difficile associated diarrhea

Exclusion Criteria:

• Patients < 18 years old

Related Conditions & MeSH terms

• Clostridium Infections

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 Europ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants without another Clostridium difficile infection after fecal microbiota transplantation (FMT)	A 24 month follow-up allows analyses of long-term effects of FMT	24 months after FMT
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	A 24 month follow-up allows analyses of long-term effects of FMT	24 months after FMT

External Links

•   Website study group