NCT06669936

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
Last Updated

November 1, 2024

Status Verified

July 1, 2024

Enrollment Period

6.4 years

First QC Date

July 22, 2024

Last Update Submit

October 31, 2024

Conditions

Recurrent C. Difficile Infection

Outcome Measures

Primary Outcomes (1)

  • Clinical failure

    Recurrence of C. difficile infection as documented by worsened diarrhea symptoms and laboratory evidence for C. difficile infection in stool.

    90 days

Study Arms (1)

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

Interventions

Fecal microbiota transplantation ± bezlotoxumabDRUG

Co-administration of bezlotoxumab and FMT in patients with recurrent C. difficile infections who failed FMT alone.

Also known as: FMT; Zinplava
Zinplava/FMT

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Pregnancy.
  • Class III or above heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantationbezlotoxumab

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 22, 2024

First Posted

November 1, 2024

Study Start

May 1, 2018

Primary Completion

October 1, 2024

Study Completion

October 28, 2024

Last Updated

November 1, 2024

Record last verified: 2024-07

Locations

US(1)