Rescue FMT with Bezlotoxumab for Recurrent C. Difficile Infection (ZINFMT)

Alexander Khoruts

Status: Completed

Conditions: Recurrent C. Difficile Infection

Treatments: Drug: Fecal microbiota transplantation ± bezlotoxumab

Study type: Observational

Funder types: Other

Identifiers

NCT06669936

FMTZinplava001

Details and patient eligibility

About

The goal is to evaluate the benefit of adding bezlotoxumab to repeat fecal microbiota transplantation (FMT) in patients with recurrent Clostridioides difficile infections after failure of FMT alone.

Full description

Initial failure of FMT in breaking the cycle of recurrent C. difficile infections is associated with a greater risk of subsequent failure. Previous analysis showed that FMT failure is associated with delayed repair of fecal microbiota at one week after administration. The hypothesis underlying this trial is that increased symptom-free interval by administration of bezlotoxumab can improve the outcomes of a second FMT.

Enrollment: 24 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Informed consent.
2. Diagnosis of recurrent C. difficile infection based on symptoms and laboratory confirmation.
3. Failure of standard antibiotic therapies prior to the initial FMT

Exclusion criteria

1. Pregnancy.
2. Class III or above heart failure.

Trial design

24 participants in 1 patient group

Zinplava/FMT

Description:

Patients with recurrent C. difficile infections, who failed FMT. This cohort includes patients treated with a combination of bezlotoxumab (Zinplava) and 2nd FMT.

Treatment:

Drug: Fecal microbiota transplantation ± bezlotoxumab