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
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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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: FMT
FMT
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Biological: FMT |
Active Comparator: Standard
Vancomycin
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Drug: Vancomycin |
- Resolution of diarrhea [ Time Frame: 2 weeks ]Resolution of diarrhea
- Patient acceptance [ Time Frame: 2 weeks ]
- Persitence of FMT [ Time Frame: 26 weeks ]

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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

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
Contact: Martin Goetz, Prof | martin.goetz@med.uni-tuebingen.de |
Germany | |
Universitaetsklinikum Tuebingen | |
Tuebingen, Germany, 72076 | |
Contact: Martin Goetz, Prof. martin.goetz@med.uni-tuebingen.de | |
Principal Investigator: Martin Goetz, Prof. |
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 |
Fecal microbiota transplantation microbiota clostridium difficile clostridium difficile infection Efficacy of FMT |
Clostridium Infections Infections Gram-Positive Bacterial Infections Bacterial Infections |
Bacterial Infections and Mycoses Vancomycin Anti-Bacterial Agents Anti-Infective Agents |