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Trial record 1 of 1 for:    NCT01942447
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Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis (TOCSIN)

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. Identifier: NCT01942447
Recruitment Status : Unknown
Verified October 2013 by Martin Goetz, University Hospital Tuebingen.
Recruitment status was:  Not yet recruiting
First Posted : September 16, 2013
Last Update Posted : October 11, 2013
Information provided by (Responsible Party):
Martin Goetz, University Hospital Tuebingen

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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Clostridium Difficile Infection Biological: FMT Drug: Vancomycin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: FMT
Biological: FMT
Active Comparator: Standard
Drug: Vancomycin

Primary Outcome Measures :
  1. Resolution of diarrhea [ Time Frame: 2 weeks ]
    Resolution of diarrhea

Secondary Outcome Measures :
  1. Patient acceptance [ Time Frame: 2 weeks ]

Other Outcome Measures:
  1. Persitence of FMT [ Time Frame: 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01942447

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Contact: Martin Goetz, Prof

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Universitaetsklinikum Tuebingen
Tuebingen, Germany, 72076
Contact: Martin Goetz, Prof.   
Principal Investigator: Martin Goetz, Prof.         
Sponsors and Collaborators
University Hospital Tuebingen
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Responsible Party: Martin Goetz, Univ.-Prof. Dr. med. Martin Goetz, University Hospital Tuebingen Identifier: NCT01942447    
Other Study ID Numbers: UKT-FMT
UKT ( Other Identifier: UKT )
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: October 11, 2013
Last Verified: October 2013
Keywords provided by Martin Goetz, University Hospital Tuebingen:
Fecal microbiota transplantation
clostridium difficile
clostridium difficile infection
Efficacy of FMT
Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Anti-Bacterial Agents
Anti-Infective Agents