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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||May 2015|
Active Comparator: Standard
- Resolution of diarrhea [ Time Frame: 2 weeks ]Resolution of diarrhea
- Patient acceptance [ Time Frame: 2 weeks ]
- Persitence of FMT [ Time Frame: 26 weeks ]
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, Proffirstname.lastname@example.org|
|Tuebingen, Germany, 72076|
|Contact: Martin Goetz, Prof. email@example.com|
|Principal Investigator: Martin Goetz, Prof.|