Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis

Clostridium Difficile Infection Clinical Trial

— TOCSIN  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01942447
• Other study ID #: UKT-FMT
• Secondary ID: UKT
• Status: Not yet recruiting
• Phase: N/A
• First received: September 5, 2013
• Last updated: October 10, 2013
• Start date: October 2013
• Est. completion date: May 2015

Study information

• Verified date: October 2013
• Source: University Hospital Tuebingen
• Contact: Martin Goetz, Prof
• Email: martin.goetz[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Health authority: Germany: Ethikkommission Tuebingen
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile
• Clostridium Difficile Infection

Intervention

Biological:
• FMT

Drug:
• Vancomycin

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Persitence of FMT		26 weeks	No
Primary	Resolution of diarrhea	Resolution of diarrhea	2 weeks	No
Secondary	Patient acceptance		2 weeks	No