About this trial
The emergence of multidrug-resistant organisms (MDROs) has become one of the major threats to the healthcare system in Hong Kong in recent years. The situation is particularly worrisome for carbapenem-resistant Enterobacteriaceae (CRE). Taking Queen Mary Hospital as an example, the number of CRE cases has surged from 24 in year 2014 to 625 in year 2021. The case burden in Hong Kong is therefore substantial when all 43 public hospitals and institutions in Hong Kong are considered. With the widespread use of broad-spectrum antibiotics and active case screening, the number of CRE cases is expected to further increase in an exponential manner.
Given that colonization with MDROs is due to gut dysbiosis from antibiotic use, a normal intestinal microbiota is apparently crucial in protecting hosts from colonization with MDROs including CRE. Fecal microbiota transplantation (FMT), which involves the infusion of stool from a healthy donor to the gastrointestinal (GI) tract of a recipient, has gained popularity in recent years to restore colonic microbial diversity in various diseases associated with gut dysbiosis, e.g. Clostridium difficile (CD) infection, ulcerative colitis and even metabolic diseases. The investigators aim to conduct a double-blind randomized controlled trial to evaluate the benefit of FMT via upper GI delivery (oral capsules) on CRE clearance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All adult patients aged 18 or above admitted to the medical ward of Queen Mary Hospital, the teaching hospital of the University of Hong Kong
Rectal swabs or stool specimens showing the presence of CRE
Positive CRE specimen within one week of commencement
Disqualifiers
Pregnancy
Severe immunodeficiency (e.g. advanced human immunodeficiency virus infection (CD4 lymphocyte count ≤200/mm3), myelosuppressive chemotherapy)
Significant neutropenia (absolute neutrophil count ≤1.0 x 109/L)
Recent antibiotic use within 30 days prior to consent
Trial design
Parallel
Treatments tested in this trial
Fecal microbiota transplant
Biological/VaccineActive comparator will receive oral capsules form of FMT for 2 days (the day of first ingestion as day 0)
Sham fecal microbiota transplant
Biological/VaccinePlacebo comparator will receive placebo oral capsules FMT for 2 days (the day of first ingestion as day 0)
Treatment groups
Trial outcomes
Primary outcomes
CRE clearance rate
CRE clearance rate via FMT oral capsules
Secondary outcomes
CRE clearance rate
CRE clearance rate post-FMT
All-cause mortality
All-cause mortality post-FMT
Locations
Sponsors and contacts
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