MedTrace Logo

Fecal Microbiota Transplantation for Decolonization of Carbapenem-resistant Enterobacteriaceae

NCT05981430 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-13

No results posted yet for this study

Summary

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.

Conditions

  • Carbapenem-Resistant Enterobacteriaceae Infection
  • Fecal Microbiota Transplantation

Interventions

BIOLOGICAL

Fecal microbiota transplant

Active comparator will receive oral capsules form of FMT for 2 days (the day of first ingestion as day 0)

BIOLOGICAL

Sham fecal microbiota transplant

Placebo comparator will receive placebo oral capsules FMT for 2 days (the day of first ingestion as day 0)

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Ka Shing Cheung · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-11-01
Primary Completion
2027-12-31
Completion
2028-06-30

More Related Trials

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 NCT05981430 on ClinicalTrials.gov