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NOT YET RECRUITING
NCT05981430
NA

Fecal Microbiota Transplantation for Decolonization of Carbapenem-resistant Enterobacteriaceae

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

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.

Official title: Oral Fecal Microbiota Transplant Capsules for Decolonization of Carbapenem-resistant Enterobacteriaceae: a Double-blind Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-11-01

Completion Date

2028-06-30

Last Updated

2026-05-13

Healthy Volunteers

No

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)