MedTrace Logo

FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI

NCT02255305 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-03-03

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to determine the safety and efficacy of Fecal Microbiota Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI) as compared to standard antibiotic therapy. Patients who have tested positive for CDI within 90 days of an admission for relapse of CDI will be approached to participate in this open-label, randomized controlled trial. Patients will either be randomized to the intervention group (receive FMT via retention enema) or the control group (receive antimicrobials targeting CDI).

Conditions

  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

FMT

Patients in the FMT group will receive \~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.

DRUG

Antimicrobials

Patients randomized to the control group will receive antimicrobials targeting C. difficile.

Sponsors & Collaborators

  • Endeavor Health

    lead OTHER

Principal Investigators

  • Becky Smith, MD · Endeavor Health

  • Jennifer Grant, MD · Endeavor Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02255305 on ClinicalTrials.gov