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Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis (TOCSIN)

Primary Purpose

Clostridium Difficile, Clostridium Difficile Infection

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
FMT
Vancomycin
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile focused on measuring Fecal microbiota transplantation, microbiota, clostridium difficile, clostridium difficile infection, Efficacy of FMT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • recurrent or refractory CDI
  • previous antimicrobial therapy includes at least on course of vancomycin 4x125 (or higher doses) for at least 7d
  • CDI, defined as: 3 or more loose bowel movements/d AND (presence of C.diff. toxin in stools or toxin producing C. diff. strain) OR (endoscopic or histologic evidence of pseudomembraneous colitis)

Exclusion Criteria:

  • no informed consent
  • no ability to provide informed consent
  • immune suppression (continuous immune-suppressive drugs; steroids: prednisolone-equivalent > 20 mg for 14d or longer)
  • lack of appropriate donor
  • pregnancy

Sites / Locations

  • Universitaetsklinikum Tuebingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FMT

Standard

Arm Description

FMT

Vancomycin

Outcomes

Primary Outcome Measures

Resolution of diarrhea
Resolution of diarrhea

Secondary Outcome Measures

Patient acceptance

Full Information

First Posted
September 5, 2013
Last Updated
October 10, 2013
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT01942447
Brief Title
Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis
Acronym
TOCSIN
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

5. Study Description

Brief Summary
The host gastrointestinal microbiota is significantly influenced by antibiotic treatment which might favor Clostridium difficile infection (CDI), a frequent cause of community- and hospital-acquired, potentially life-threatening diarrhoea. CDI is followed by recurrence in 19-35% of patients despite adequate first line antimicrobial therapy. Currently there is no standardized therapy of recurrent or refractory CDI, but recent studies show remarkable effects of fecal microbiota transplantation (FMT). In the current project, we aim to ideally match host and donor for FMT success in recurrent or refractory CDI. We will establish a clinical standard operating protocol for FMT, we will evaluate its safety and efficacy, and the patient acceptance and quality of life before and after FMT. We will analyse persistence of the donor microbiota within the recipient, define predictive clinical recipient and donor factors for FMT success and correlate them with microbial host and donor metagenomics. We hypothesize that our work will yield novel, individualized strategies for recurrent or refractory CDI. In perspective, our results may be expanded to treatment of other inflammory bowel diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile, Clostridium Difficile Infection
Keywords
Fecal microbiota transplantation, microbiota, clostridium difficile, clostridium difficile infection, Efficacy of FMT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FMT
Arm Type
Experimental
Arm Description
FMT
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Vancomycin
Intervention Type
Biological
Intervention Name(s)
FMT
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Primary Outcome Measure Information:
Title
Resolution of diarrhea
Description
Resolution of diarrhea
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Patient acceptance
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Persitence of FMT
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: recurrent or refractory CDI previous antimicrobial therapy includes at least on course of vancomycin 4x125 (or higher doses) for at least 7d CDI, defined as: 3 or more loose bowel movements/d AND (presence of C.diff. toxin in stools or toxin producing C. diff. strain) OR (endoscopic or histologic evidence of pseudomembraneous colitis) Exclusion Criteria: no informed consent no ability to provide informed consent immune suppression (continuous immune-suppressive drugs; steroids: prednisolone-equivalent > 20 mg for 14d or longer) lack of appropriate donor pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Goetz, Prof
Email
martin.goetz@med.uni-tuebingen.de
Facility Information:
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Goetz, Prof.
Email
martin.goetz@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Martin Goetz, Prof.

12. IPD Sharing Statement

Learn more about this trial

Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis

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