Multidrug Resistant OrganismsFEMRONCT05742074
The Effect of Faecal Microbiota Transplantation (FMT) on Eradication of Multidrug Resistant Organisms (MRO) in Intestinal Carriers
A study testing Faecal microbiota transplantation in people with Multidrug Resistant Organisms and Faecal Microbiota Transplantation, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the effect of faecal microbiota transplantation (FMT) on eradication of multidrug resistant organisms (MRO) in the intestine. Ultimately, it would be possible to prevent invasive infections with MRO that are difficult to treat and require last-resort antibiotics. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Multidrug Resistant Organisms, Faecal Microbiota Transplantation
- What is being tested?
- Faecal microbiota transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Mar 2023to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: minimum 18 years
- Positive rectal PCR and/or culture for MRO
- Ability to speak and understand Danish or English
- Capable of swallowing the capsules
Who cannot join
- Current invasive infection with an MRO e.g. in abdomen, bloodstream or symptomatic urinary tract infection.
- Severe immune deficiency (defined as current chemo treatment or neurofilocytes < 1000/mm3
- Pancreatitis, defined by pancreatic amylases above the upper reference limit
- Planned or recent abdominal surgery (within 14 days)
- Parenteral nutrition
- Current antibiotic treatment of the same MRO as intestinal carriage
Show all 9Show fewer
- Terminal disease with expected survival under three months
- Sepsis defined according to Surviving Sepsis Campaign guidelines
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hvidovre Hospital, Copenhagen University
Hvidovre, Copenhagen, 2650
About this study
Official title: The Effect of Faecal Microbiota Transplantation (FMT) on Eradication of Multidrug Resistant Organisms (MRO) in Intestinal Carriers - a Multicentre, Randomized, Double-blinded and Placebo-controlled Study
The aim of this study is to investigate the effect of faecal microbiota transplantation (FMT) on eradication of multidrug resistant organisms (MRO) in the intestine. Ultimately, it would be possible to prevent invasive infections with MRO that are difficult to treat and require last-resort antibiotics. The investigators hypothesize that FMT induce intestinal resistance towards colonization with MRO e.g. Vancomycin resistant Enterococcus Faecium (VRE), carbapenemase-producing Enterobacterales (CPE) and extended-spectrum beta-lactamase producing Enterobacterales (ESBL-E).
Read the detailed description
The study is designed as a randomized, double-blinded and placebo-controlled clinical trial. The participants (n = 80) will be randomized 1:1 to FMT or placebo. FMT or placebo consist of 25-30 capsules which need to be consumed on one day or alternatively consumed over three consecutive days, if one day is unacceptable to the participant. At baseline, eight weeks, and 16 weeks rectal swabs for PCR and culture will be taken. Regarding VRE and CPO, there are specific PCRs followed by confirmatory culture, whereas ESBL-E is detected by culture of rectal swab. Furthermore, participants will be asked to deliver faecal samples as well at baseline and 16 weeks post FMT to examine changes in the intestinal microbiome.
- Being tested
- Faecal microbiota transplantation, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal microbiota transplantationOther
25-30 capsules of faecal material
PlaceboOther
25-30 placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| FMT (faecal microbiota transplantation) | Experimental | 25-30 capsules of faecal material. Receives: Other: Faecal microbiota transplantation |
| Placebo | Placebo comparator | 25-30 placebo capsules. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with MRO clearance
Number of participants with MRO clearance after eight weeks. This will be measured on rectal samples that will undergo PCR/culture for ESBL, VRE and CPO. The results from the test will be positive or negative.
Measured: 8 weeks
Secondary outcomes (5)
Number of participants with MRO clearance
Number of participants with negative PCR for MRO on rectal swab and faecal culture negative for MRO after 16 weeks. This will be measured on rectal samples that will undergo PCR/culture for ESBL, VRE and CPO. The result from the test will be positive or negative
Measured: 16 weeks
Number of participants with adverse events.
Number of participants with adverse events both severe and non-severe.
Measured: 8 weeks, 16 weeks and 6 months.
Comparison of the frequency of invasive infections
Comparison of the frequency of invasive infections with the same MRO as the intestinal carriage between the FMT and the placebo group.
Measured: 6 months
Comparison of mortality rates, frequency of hospitalization and isolation between the FMT and the placebo group.
Comparison of mortality rates, frequency of hospitalization and isolation between the FMT and the placebo group.
Measured: 6 months
Comparison of changes in the diversity of the intestinal microbiome between the FMT group and the placebo group.
Comparison of changes in the diversity of the intestinal microbiome between the FMT group and the placebo group.
Measured: 8 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start24 Mar 2023
- Primary completion11 Feb 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidrug Resistant OrganismsStudies 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
- Model description
- Randomized.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Munk Petersen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742074
- Sponsor's protocol ID
- H-22040517
- Acronym
- FEMRO
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Faecal Microbiota Transplantation (FMT) on Eradication of Multidrug Resistant Organisms (MRO) in Intestinal Carriers - a Multicentre, Randomized, Double-blinded and Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05742074
- Acronym / sponsor ID
- FEMRO / H-22040517
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Zealand University Hospital
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 23 Feb 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 aim of this study is to investigate the effect of faecal microbiota transplantation (FMT) on eradication of multidrug resistant organisms (MRO) in the intestine. Ultimately, it would be possible to prevent invasive infections with MRO that are difficult to treat and require last-resort antibiotics. The investigators hypothesize that FMT induce intestinal resistance towards colonization with MRO e.g. Vancomycin resistant Enterococcus Faecium (VRE), carbapenemase-producing Enterobacterales (CPE) and extended-spectrum beta-lactamase producing Enterobacterales (ESBL-E).
Detailed description
The study is designed as a randomized, double-blinded and placebo-controlled clinical trial. The participants (n = 80) will be randomized 1:1 to FMT or placebo. FMT or placebo consist of 25-30 capsules which need to be consumed on one day or alternatively consumed over three consecutive days, if one day is unacceptable to the participant. At baseline, eight weeks, and 16 weeks rectal swabs for PCR and culture will be taken. Regarding VRE and CPO, there are specific PCRs followed by confirmatory culture, whereas ESBL-E is detected by culture of rectal swab. Furthermore, participants will be asked to deliver faecal samples as well at baseline and 16 weeks post FMT to examine changes in the intestinal microbiome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized.
| Arm | Type | Receives |
|---|---|---|
| FMT (faecal microbiota transplantation) | Experimental | Other: Faecal microbiota transplantation25-30 capsules of faecal material. |
| Placebo | Placebo comparator | Other: Placebo25-30 placebo capsules. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: minimum 18 years
- Positive rectal PCR and/or culture for MRO
- Ability to speak and understand Danish or English
- Capable of swallowing the capsules
Key exclusion criteria (9 listed)
- Current invasive infection with an MRO e.g. in abdomen, bloodstream or symptomatic urinary tract infection.
- Severe immune deficiency (defined as current chemo treatment or neurofilocytes < 1000/mm3
- Pancreatitis, defined by pancreatic amylases above the upper reference limit
- Planned or recent abdominal surgery (within 14 days)
- Parenteral nutrition
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 |
|---|---|---|
| Faecal microbiota transplantation25-30 capsules of faecal material | Other | FMT (faecal microbiota transplantation) |
| Placebo25-30 placebo capsules | Other | Placebo |
Primary outcome
Number of participants with MRO clearance
Time frame: 8 weeks
Number of participants with MRO clearance after eight weeks. This will be measured on rectal samples that will undergo PCR/culture for ESBL, VRE and CPO. The results from the test will be positive or negative.
5 secondary outcomes
Number of participants with MRO clearance
Time frame: 16 weeks
Number of participants with adverse events.
Time frame: 8 weeks, 16 weeks and 6 months.
Comparison of the frequency of invasive infections
Time frame: 6 months
Comparison of mortality rates, frequency of hospitalization and isolation between the FMT and the placebo group.
Time frame: 6 months
Comparison of changes in the diversity of the intestinal microbiome between the FMT group and the placebo group.
Time frame: 8 weeks and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faecal microbiota transplantation in people with Multidrug Resistant Organisms and Faecal Microbiota Transplantation, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with MRO clearance (time frame: 8 weeks). 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 17 Apr 2026.