Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection (FACIT)

University of Aarhus

Status and phase: Completed; Phase 3

Conditions: Clostridium Difficile Infection

Treatments: Other: Fecal microbiota transplantation; Drug: Fidaxomicin; Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02743234

FACIT

Details and patient eligibility

About

Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection

Enrollment: 64 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin

Exclusion criteria

1. Pregnancy or breastfeeding
2. Does not speak or understand the Danish language
3. Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin
4. fulminant colitis which contraindicates medical treatment
5. physician's evaluation that the patient cannot tolerate project inclusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 3 patient groups

FMT

Experimental group

Description:

Fecal microbiota transplantation (FMT) following 4-10 days of vancomycin 125 mg x 4, using cryopreserved feces from a healthy anonymous donor

Treatment:

Other: Fecal microbiota transplantation

Fidaxomicin

Active Comparator group

Description:

10 days fidaxomicin 200 mg x 2 daily

Treatment:

Drug: Fidaxomicin

Vancomycin

Active Comparator group

Description:

10 days vancomycin 125 x 4 daily

Treatment:

Drug: Vancomycin