MedTrace Logo

Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection

NCT03427229 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2018-02-09

No results posted yet for this study

Summary

Fecal microbiota transplantation (FMT) is acknowledged as a highly effective treatment for recurrent Clostridium difficile infection (CDI). Usually single fecal infusion achieves satisfactory cure rates of recurrent CDI). However, several retrospective studies show that severe clinical picture of recurrent CDI is a risk factor for the failure of single-infusion FMT, suggesting that multiple fecal infusions are required to cure this condition.

This is an open-label randomized clinical trial aiming to assess if multiple-infusion FMT is more effective than single-infusion FMT in curing severe CDI

Conditions

  • Clostridium Difficile
  • Pseudomembranous Colitis

Interventions

BIOLOGICAL

Single-infusion FMT

Patients will receive a single fecal infusion by colonoscopy

DRUG

Vancomycin (before randomization)

Vancomycin is administered in all patients for 3 days before randomization. Then vancomycin is stopped and patients are randomized to single-infusion FMT or multiple-infusion FMT.

BIOLOGICAL

multiple-infusion FMT

Patients will receive multiple fecal infusions by colonoscopy

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-10-30
Completion
2017-10-30

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 NCT03427229 on ClinicalTrials.gov