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Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

NCT02743234 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-10-15

No results posted yet for this study

Summary

Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection

Conditions

  • Clostridium Difficile Infection

Interventions

OTHER

Fecal microbiota transplantation

FMT follows 4-10 days of vancomycin 125 mg x 4 daily

DRUG

Fidaxomicin

Fidaxomicin 200 mg x 2 daily for 10 days

DRUG

Vancomycin

Vancomycin 125 mg x 4 daily for 10 days

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Jens F Dahlerup, MD DrMSc · Associate professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-02-28
Completion
2019-08-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

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 NCT02743234 on ClinicalTrials.gov