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

Efficacy Fo Oral Capsule FMT Combined with Bezlotoxumab Following Initial Failure of FMT Alone

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.

Study Overview

• Status: Completed
• Conditions: Recurrent C. Difficile Infection
• Intervention / Treatment: Drug: Fecal microbiota transplantation ± bezlotoxumab

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with history of recurrent C. difficile infection who suffered a relapse without a new antibiotic provocation within 90 days of FMT.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Zinplava/FMT; Patients with recurrent C. difficile infections, who failed FMT. This cohort includes patients treated with a combination of bezlotoxumab (Zinplava) and 2nd FMT.	Drug: Fecal microbiota transplantation ± bezlotoxumab; Co-administration of bezlotoxumab and FMT in patients with recurrent C. difficile infections who failed FMT alone.; Other Names: FMT; Zinplava

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical failure	Recurrence of C. difficile infection as documented by worsened diarrhea symptoms and laboratory evidence for C. difficile infection in stool.	90 days

Collaborators and Investigators

• Sponsor: Alexander Khoruts

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 28, 2024

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: FMTZinplava001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All relevant data are going to be published.

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No