NCT02681068

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

4.2 years

First QC Date

February 2, 2016

Last Update Submit

May 3, 2017

Conditions

Clostridium Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    24 months after FMT

Interventions

Fecal microbiota transplantation (FMT)OTHER

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with recurrent Clostridium difficile infection

You may qualify if:

  • Patients with Clostridium difficile associated diarrhea

You may not qualify if:

  • Patients \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Cologne

Cologne, 50937, Germany

RECRUITING

Related Publications (3)

  • 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. No abstract available.

    PMID: 26163107RESULT

  • Bestfater C, Vehreschild MJGT, Stallmach A, Tuffers K, Erhardt A, Frank T, Gluck T, Goeser F, Sellge G, Solbach P, Eisenlohr H, Storr M; German Clinical Microbiome Study Group (GCMSG). Clinical effectiveness of bidirectional fecal microbiota transfer in the treatment of recurrent Clostridioides difficile infections. Dig Liver Dis. 2021 Jun;53(6):706-711. doi: 10.1016/j.dld.2021.02.022. Epub 2021 Mar 18.

    PMID: 33744169DERIVED

  • 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.

    PMID: 27658471DERIVED

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Maria Vehreschild, MD

    University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Vehreschild, MD

CONTACT

+49 221 478 88794maria.vehreschild@uk-koeln.de

Stefan Hagel, MD

CONTACT

+49 3641 9324590stefan.hagel@med.uni-jena.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 12, 2016

Study Start

January 1, 2015

Primary Completion

March 1, 2019

Study Completion

December 1, 2019

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)