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Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection

NCT02686645 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-09-27

No results posted yet for this study

Summary

Interventional, single arm, single-centre trial to evaluate the effectiveness and safety of fecal microbiota therapy (FMT) in the investigators population.

Conditions

  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

Fecal Microbiota

The fecal microbiota will be by retention enema administered through a rectal tube.

DRUG

vancomycin

All subjects will be pre-treated with vancomycin 125 mg po qid X 7 days prior to the fecal microbiota.

DRUG

Loperamide

The subject will take 4 mg of loperamide after the morning bowel prep (approximately 1 hour prior to the procedure) and 2 mg again after the procedure.

DRUG

metronidazole

If unable to tolerate vancomycin, then it will be substituted with metronidazole 500 mg po tid X 7 days prior to the fecal microbiota.

Sponsors & Collaborators

  • Queen Elizabeth II Health Sciences Centre

    lead OTHER

Principal Investigators

  • Ian R Davis, MD,FRCPC · Dalhousie University, Department of Medicine, Division Infectious Diseases

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2021-12-31
Completion
2021-12-31

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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 NCT02686645 on ClinicalTrials.gov