Overview

FMT for Moderate to Severe CDI: A Randomised Study With Concurrent Stool Microbiota Assessment

Status:
Active, not recruiting

Trial end date:
2021-12-01

Target enrollment:
0

Participant gender:
All

Summary

Clostridium difficile infection (CDI) is a leading cause of hospital-associated gastrointestinal illness, associated with significant morbidity and mortality and has a high burden on health-care system. The incidence of CDI has increased to epidemic proportion worldwide over the past decade. Community-acquired CDI, elderly and hospitalized patients receiving antibiotics are the main group at risk for developing CDI. Currently, the first-line treatment for C. difficile-associated diarrhea includes cessation of the antibiotic implicated in the development of CDI, treatment with metronidazole or vancomycin and recently Fidaxomicin which is yet to be available in Hong Kong. However, disease recurrence is an increasing problem and 20% to 60% of patients experience at least one recurrence within a few weeks of completion of antibiotic treatment. Moreover, an increasing number of patients who require life-saving emergency colectomy experience persistent CDI after surgery. Until recently, an effective treatment against recurrent CDI is not available. Generally, repeated and extended courses of vancomycin are prescribed. Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to affected subjects has attracted great interest in recent years and is now recommended as the most effective therapy for CDI not responding to standard therapies. Systematic reviews of prospective trials, case series and one randomized controlled trial have shown an overall cure rate of close to 100%. More than 50% of patients stated they would have FMT as their preferred first treatment option if CDI were to recur. This proposal aims to investigate the efficacy of FMT as first line therapy in patients with severe CDI and to assess changes in the fecal microbiota after FMT using pyrosequencing techniques.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Chinese University of Hong Kong

Treatments:

Vancomycin

Criteria

Inclusion Criteria:

1. C. difficile infection defined as diarrhea (≥3 soft, loose or watery stools per day
for at least 2 consecutive days or ≥8 soft or loose stools in 48 hours) and a positive
stool test for C. difficile toxin; and

2. Age ≥ 18; and

3. Written informed consent obtained

Exclusion Criteria:

1. The presence of human immunodeficiency virus (HIV) infection with a CD4 count of less
than 240

2. Pregnancy

3. GI Bleeding

4. Acute coronary syndrome