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NCT05981430: FMT
Fecal Microbiota Transplantation for Decolonization of Carbapenem-resistant Enterobacteriaceae
NA trial testing Fecal microbiota transplant in Carbapenem-Resistant Enterobacteriaceae Infection in 80 participants. Not yet recruiting.
19 August 2025
Quick facts
| Lead sponsor | The University of Hong Kong |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 November 2026 |
| Primary completion | 19 August 2025 |
| Estimated completion | 30 June 2028 |
Drugs / interventions tested
- Fecal microbiota transplant — full drug profile →
- Sham fecal microbiota transplant — full drug profile →
Conditions studied
- Carbapenem-Resistant Enterobacteriaceae Infection — all drugs for Carbapenem-Resistant Enterobacteriaceae Infection →
- Fecal Microbiota Transplantation — all drugs for Fecal Microbiota Transplantation →
Sponsor
The University of Hong Kong
Who can join
Adults 18 to 90, any sex, with Carbapenem-Resistant Enterobacteriaceae Infection or Fecal Microbiota Transplantation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 lower GI delivery (enema) on CRE clearance.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Antimicrobial Resistance: The Answers.
Millar BC, Cates MJ, Torrisi MS, Round AJ, et al · · 2026 · PMID 41727556 · DOI 10.3389/bjbs.2026.15559
Verify or expand the search:
- PubMed search for NCT05981430
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fecal microbiota transplant
Trials testing the same drug.
- NCT05998213 — Transfer of Feces in Ulcerative Colitis 2 · Phase 2 · completed
- NCT03367910 — Fecal Microbiota Transplantation (FMT) for MDRO UTI · Phase 1, PHASE2 · completed
Other recruiting trials for Carbapenem-Resistant Enterobacteriaceae Infection
Currently open trials in the same condition.
- NCT05979545 — EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics · Phase 4 · recruiting
- NCT06051513 — Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae I · NA · recruiting
- NCT07086391 — Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumo · recruiting
- NCT05871476 — Interventions to Decrease CRE Colonization and Transmission Between Hospitals, Households, Communities and Domesticated · NA · recruiting
- NCT04535661 — Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in Children · recruiting
Other The University of Hong Kong trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05981430 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Hong Kong
- Last refreshed: 7 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05981430.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing