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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)

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Martin Goetz, University Hospital Tuebingen

Study Description
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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

Study Design
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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

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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01942447


Contacts
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Contact: Martin Goetz, Prof martin.goetz@med.uni-tuebingen.de

Locations
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Germany
Universitaetsklinikum Tuebingen
Tuebingen, Germany, 72076
Contact: Martin Goetz, Prof.       martin.goetz@med.uni-tuebingen.de   
Principal Investigator: Martin Goetz, Prof.         
Sponsors and Collaborators
University Hospital Tuebingen
More Information
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Responsible Party: Martin Goetz, Univ.-Prof. Dr. med. Martin Goetz, University Hospital Tuebingen
ClinicalTrials.gov 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
microbiota
clostridium difficile
clostridium difficile infection
Efficacy of FMT
Additional relevant MeSH terms:
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Clostridium Infections
Infections
Gram-Positive Bacterial Infections
Bacterial Infections
 Bacterial Infections and Mycoses
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents