Carbapenem-Resistant Enterobacteriaceae ColonizationNCT07265817
Fecal Microbiota Transplantation for Decolonization of Multidrug-resistant Microorganisms
A study testing Fecal Microbial transplant Capsules in people with Carbapenem-Resistant Enterobacteriaceae Colonization, run by Kyungpook National University Hospital.
Trial summary
The aim of the study is to see whether fecal microbiota transplantation is effective to decolonize multidrug-resistant organisms. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Carbapenem-Resistant Enterobacteriaceae Colonization
- What is being tested?
- Fecal Microbial transplant Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Oct 2027
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have positive results in PCR or culture of rectal swab.
Who cannot join
- Not provide a consent.
About this study
Official title: Fecal Microbiota Transplantation for Decolonization of Multidrug-resistant Microorganisms: Randomized Double Blinded Study
The aim of the study is to see whether fecal microbiota transplantation is effective to decolonize multidrug-resistant organisms.
- Being tested
- Fecal Microbial transplant Capsules, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbial transplant CapsulesCombination product
3 pills per day for 3 consecutive days with placebo comparatator
PlaceboCombination product
The same amount and shape capsules
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation group | Active comparator | Not described Receives: Combination Product: Fecal Microbial transplant Capsules |
| Placebo | Placebo comparator | Not described Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to negative organism
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenem-Resistant Enterobacteriaceae ColonizationStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Soo Kim, MD, PhD, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265817
- Sponsor's protocol ID
- KNUH 2023-07-013
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for Decolonization of Multidrug-resistant Microorganisms: Randomized Double Blinded Study
- ClinicalTrials.gov ID
- NCT07265817
- Acronym / sponsor ID
- KNUH 2023-07-013
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 5 Dec 2025 (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 aim of the study is to see whether fecal microbiota transplantation is effective to decolonize multidrug-resistant organisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation group | Active comparator | Combination Product: Fecal Microbial transplant Capsules |
| Placebo | Placebo comparator | Combination Product: Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have positive results in PCR or culture of rectal swab.
Key exclusion criteria (1 listed)
- Not provide a consent.
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 Microbial transplant Capsules3 pills per day for 3 consecutive days with placebo comparatator | Combination product | Fecal microbiota transplantation group |
| PlaceboThe same amount and shape capsules | Combination product | Placebo |
Primary outcome
Conversion to negative organism
Time frame: 1 year
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 5 Dec 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbial transplant Capsules in people with Carbapenem-Resistant Enterobacteriaceae Colonization, run by Kyungpook National University Hospital.
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 1 inclusion and 1 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 5 Dec 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion to negative organism (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2025.