Carbapenem-Resistant Enterobacteriaceae InfectionFMTNCT05981430
Fecal Microbiota Transplantation for Decolonization of Carbapenem-resistant Enterobacteriaceae
A study testing Fecal microbiota transplant in people with Carbapenem-Resistant Enterobacteriaceae Infection and Fecal Microbiota Transplantation, run by The University of Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carbapenem-Resistant Enterobacteriaceae Infection, Fecal Microbiota Transplantation
- What is being tested?
- Fecal microbiota transplant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Contraindications for capsule ingestion (dysphagia or gastrointestinal dysmotility).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Oral Fecal Microbiota Transplant Capsules for Decolonization of Carbapenem-resistant Enterobacteriaceae: a Double-blind Randomized Controlled 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.
Read the detailed description
CRE colonization is associated with a 16.5% risk of infection with a 10% mortality rate. CRE also poses a tremendous strain on the healthcare cost as well as the medical/nursing manpower. The hospital stay is lengthened by two-fold for CRE-infected cases compared with non-infected cases. CRE carriers frequently have to stay in acute hospitals for extended periods of time after settling their acute illnesses, both because of the logistic infeasibility of them being transferred to rehabilitation units or nursing homes, which are devoid of isolation rooms.
Proactive measures have been implemented in hospitals worldwide to prevent the spread of MDROs, especially to vulnerable individuals. Such measures usually include surveillance culture, contact tracing, isolation of carriers and environmental disinfection. Nevertheless, isolation facilities are not always readily available, particularly in resource-limited regions. In addition, contact isolation may result in various adverse effects on the mental well-being of isolated patients, such as depression, anxiety and anger. Time spent with patients in isolation by healthcare workers is less, with a negative effect on patient safety with an eight-fold increase in the risk of adverse events due to supportive care failure.
There has been a growing interest in extending FMT for the decolonization of CRE. However, most of the studies are limited to case reports or case series with small sample sizes (ranging from 10 to 39 patients) as shown by a recent systematic review. The pooled rate of CRE decolonization is promising at 62.1%. However, a randomized controlled trial (RCT) remains the most optimal study design to investigate the true beneficial effect of FMT on CRE decolonization. FMT via oral capsules has several advantages over upper GI delivery or colonoscopy. First, administration of fecal suspension via a feeding tube may not be acceptable to some patients. Second, colonoscopy carries complications of gut perforation, aspiration, and cardiopulmonary suppression from the use of sedatives, in particular among frail and elder patients. When FMT is given via oral capsules, it can even be administered in an outpatient setting, which could substantially reduce cost and waiting time.
- Being tested
- Fecal microbiota transplant, Sham fecal microbiota transplant
- Keywords
- FMT, CRE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantBiological
Active comparator will receive oral capsules form of FMT for 2 days (the day of first ingestion as day 0)
Sham fecal microbiota transplantBiological
Placebo comparator will receive placebo oral capsules FMT for 2 days (the day of first ingestion as day 0)
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplant | Active comparator | This group's subject will receive FMT oral capsules for 2 days (the day of first ingestion as day 0). Receives: Biological: Fecal microbiota transplant |
| Sham fecal microbiota transplant | Placebo comparator | This group's subject will receive Placebo FMT oral capsules for 2 days (the day of first ingestion as day 0). Receives: Biological: Sham fecal microbiota transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRE clearance rate
CRE clearance rate via FMT oral capsules
Measured: 1 month post-FMT
Secondary outcomes (2)
CRE clearance rate
CRE clearance rate post-FMT
Measured: 1 week, 2 week, 3 month, 6 month and 12 month post-FMT
All-cause mortality
All-cause mortality post-FMT
Measured: 1 month, 3 month, 6 month and 12 month post-FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carbapenem-Resistant Enterobacteriaceae InfectionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Ka Shing, The University of Hong Kong
- Investigators
- Ka Shing Cheung, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981430
- Sponsor's protocol ID
- UW 19-512
- Acronym
- FMT
- Status last verified
- May 2026
- First submitted
- 31 Jul 2023
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Backman C, Taylor G, Sales A, Marck PB. An integrative review of infection prevention and control programs for multidrug-resistant organisms in acute care hospitals: a socio-ecological perspective. Am J Infect Control. 2011 Jun;39(5):368-378. doi: 10.1016/j.ajic.2010.07.017. Epub 2011 Mar 23.
PubMed 21429622Quraishi MN, Widlak M, Bhala N, Moore D, Price M, Sharma N, Iqbal TH. Systematic review with meta-analysis: the efficacy of faecal microbiota transplantation for the treatment of recurrent and refractory Clostridium difficile infection. Aliment Pharmacol Ther. 2017 Sep;46(5):479-493. doi: 10.1111/apt.14201. Epub 2017 Jul 14.
PubMed 28707337Macareno-Castro J, Solano-Salazar A, Dong LT, Mohiuddin M, Espinoza JL. Fecal microbiota transplantation for Carbapenem-Resistant Enterobacteriaceae: A systematic review. J Infect. 2022 Jun;84(6):749-759. doi: 10.1016/j.jinf.2022.04.028. Epub 2022 Apr 21.
PubMed 35461908
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Fecal Microbiota Transplant Capsules for Decolonization of Carbapenem-resistant Enterobacteriaceae: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05981430
- Acronym / sponsor ID
- FMT / UW 19-512
- Keywords
- FMT, CRE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CRE colonization is associated with a 16.5% risk of infection with a 10% mortality rate. CRE also poses a tremendous strain on the healthcare cost as well as the medical/nursing manpower. The hospital stay is lengthened by two-fold for CRE-infected cases compared with non-infected cases. CRE carriers frequently have to stay in acute hospitals for extended periods of time after settling their acute illnesses, both because of the logistic infeasibility of them being transferred to rehabilitation units or nursing homes, which are devoid of isolation rooms.
Proactive measures have been implemented in hospitals worldwide to prevent the spread of MDROs, especially to vulnerable individuals. Such measures usually include surveillance culture, contact tracing, isolation of carriers and environmental disinfection. Nevertheless, isolation facilities are not always readily available, particularly in resource-limited regions. In addition, contact isolation may result in various adverse effects on the mental well-being of isolated patients, such as depression, anxiety and anger. Time spent with patients in isolation by healthcare workers is less, with a negative effect on patient safety with an eight-fold increase in the risk of adverse events due to supportive care failure.
There has been a growing interest in extending FMT for the decolonization of CRE. However, most of the studies are limited to case reports or case series with small sample sizes (ranging from 10 to 39 patients) as shown by a recent systematic review. The pooled rate of CRE decolonization is promising at 62.1%. However, a randomized controlled trial (RCT) remains the most optimal study design to investigate the true beneficial effect of FMT on CRE decolonization. FMT via oral capsules has several advantages over upper GI delivery or colonoscopy. First, administration of fecal suspension via a feeding tube may not be acceptable to some patients. Second, colonoscopy carries complications of gut perforation, aspiration, and cardiopulmonary suppression from the use of sedatives, in particular among frail and elder patients. When FMT is given via oral capsules, it can even be administered in an outpatient setting, which could substantially reduce cost and waiting time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplant | Active comparator | Biological: Fecal microbiota transplantThis group's subject will receive FMT oral capsules for 2 days (the day of first ingestion as day 0). |
| Sham fecal microbiota transplant | Placebo comparator | Biological: Sham fecal microbiota transplantThis group's subject will receive Placebo FMT oral capsules for 2 days (the day of first ingestion as day 0). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- Contraindications for capsule ingestion (dysphagia or gastrointestinal dysmotility).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantActive comparator will receive oral capsules form of FMT for 2 days (the day of first ingestion as day 0) | Biological | Fecal microbiota transplant |
| Sham fecal microbiota transplantPlacebo comparator will receive placebo oral capsules FMT for 2 days (the day of first ingestion as day 0) | Biological | Sham fecal microbiota transplant |
Primary outcome
CRE clearance rate
Time frame: 1 month post-FMT
CRE clearance rate via FMT oral capsules
2 secondary outcomes
CRE clearance rate
Time frame: 1 week, 2 week, 3 month, 6 month and 12 month post-FMT
All-cause mortality
Time frame: 1 month, 3 month, 6 month and 12 month post-FMT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 21429622Backman C, Taylor G, Sales A, Marck PB. An integrative review of infection prevention and control programs for multidrug-resistant organisms in acute care hospitals: a socio-ecological perspective. Am J Infect Control. 2011 Jun;39(5):368-378. doi: 10.1016/j.ajic.2010.07.017. Epub 2011 Mar 23.
- Background: PubMed 28707337Quraishi MN, Widlak M, Bhala N, Moore D, Price M, Sharma N, Iqbal TH. Systematic review with meta-analysis: the efficacy of faecal microbiota transplantation for the treatment of recurrent and refractory Clostridium difficile infection. Aliment Pharmacol Ther. 2017 Sep;46(5):479-493. doi: 10.1111/apt.14201. Epub 2017 Jul 14.
- Background: PubMed 35461908Macareno-Castro J, Solano-Salazar A, Dong LT, Mohiuddin M, Espinoza JL. Fecal microbiota transplantation for Carbapenem-Resistant Enterobacteriaceae: A systematic review. J Infect. 2022 Jun;84(6):749-759. doi: 10.1016/j.jinf.2022.04.028. Epub 2022 Apr 21.
- Individual participant dataSharing planned: No
Related trials for Carbapenem-Resistant Enterobacteriaceae Infection
RecruitingObservational study
Aztreonam-Avibactam in Immunocompromised Hosts
Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruitingObservational study
Predictive Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae
Hemato-oncologic Patients, Colonization
Not yet recruitingPhase 2
A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization
Clostridium Infections, Methicillin-resistant Staphylococcus Aureus (MRSA)
Active, not recruiting
Study of Probiotic Adjunctive Therapy for Decolonization of Carbapenem-Resistant Enterobacterales
Enterobacteriaceae Infections, Carrier State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ka Shing Cheung principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplant in people with Carbapenem-Resistant Enterobacteriaceae Infection and Fecal Microbiota Transplantation, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ka Shing Cheung (22554769, cks634@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRE clearance rate (time frame: 1 month post-FMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05981430, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.