Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis (TOCSIN)

University Hospital Tuebingen

Status: Unknown

Conditions: Clostridium Difficile; Clostridium Difficile Infection

Treatments: Biological: FMT; Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01942447

UKT (Other Identifier)

UKT-FMT

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

FMT

Experimental group

Description:

FMT

Treatment:

Biological: FMT

Standard

Active Comparator group

Description:

Vancomycin

Treatment:

Drug: Vancomycin