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:
Participant gender:
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.