Resistance BacterialPhase 2/3DEKODONNCT04188743
Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)
A Phase 2/3 study testing Allogenic FMT and Autologous FMT in people with Resistance Bacterial, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Colonization by Multiple Drug Resistant Organisms (MDROs) during patient hospitalization requires expensive isolation measures and renders the return or transfer to other departments or institutions often impossible. Currently there is no specific treatment available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistance Bacterial
- What is being tested?
- Allogenic FMT and Autologous FMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Dec 2019to 30 Dec 2025
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be at least 18 years of age, and must sign the 'informed consent' form and thus agree with the data collection, sampling and FMT.
- At least 2 consecutive confirmations of MDRO colonization in faeces, which complicate the necessary follow-up and/or therapy for the patient.
- Participants must be able to endure the treatment (evaluated by treating physician).
Who cannot join
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis ...)
- Diagnosed hereditary blood disease (Haemophilia, Von Willebrand ...)
- Chronic liver disease
- Active drug use or alcohol abuse / dependence, which according to the researchers' opinion may interfere with the patient's participation in the study
- Simultaneous use of probiotics (except yoghurt)
- Existing immune deficiency (congenital or acquired), or concomitant immunomodulatory treatment (including systemic corticosteroids) in the 12 weeks prior to randomization, nasal or inhaled corticosteroid use is permitted
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- Positive pregnancy test (or potentially pregnant)
- Breastfeeding
- Severe food allergy (anaphylaxis, urticarial)
- Antibiotic treatment up to 7 days before FMT, or planned to start within one month after FMT.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000
Bruno Verhasselt, bruno.verhasselt@uzgent.be
About this study
Official title: DEKODON: Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)
Colonization by Multiple Drug Resistant Organisms (MDROs) during patient hospitalization requires expensive isolation measures and renders the return or transfer to other departments or institutions often impossible. Currently there is no specific treatment available. Patients have to wait for spontaneous clearance which can take months or does not happen at all.
The study will test the effect of Fecal Microbiota Transfer (FMT) on gut MDRO colonization. The focus will be on patients with a long-term colonization by Gram-negative bacteria for which isolation is warranted. Participants will be randomized into two treatment groups; allogenic FMT versus autologous FMT. A third group of participants will be monitored but will not receive an FMT. Decolonization rate will be compared one month after treatment. Additionally gut microbial composition will be studied up to one year after FMT.
Read the detailed description
This double-blind controlled randomized study will test the efficacy of Fecal Microbiota Transfer (FMT) on gut Multiple Drug Resistant Organism (MDRO) colonization.
Participants:
The study targets hospitalized patients (>18 years old) that need to stay in isolation because of colonization by Carbapenem-resistant Enterobacteriales (CRE), non-E. coli Enterobacteriales that produce extended spectrum beta-lactamase (ESBL) or Multi Drug Resistant (MDR) Pseudomonas and MDR Acinetobacter species. Participants will be randomized in two groups (allogenic and autologous FMT). Additionally a third group of participants will be monitored without intervention.
Treatment:
Participants in the allogenic FMT- group will receive treatment using healthy donor microbiota preferably through naso-duodenal/-jejunal administration (Cortrak). Donor material will be supplied by the Ghent Stool Bank. The colonization status will be monitored on a regular basis (at least once per week) by culturing fecal swabs. Additionally fecal samples will be taken on fixed time points for microbial composition analysis (16S ribosomal ribonucleic acid metagenomics).
Controls:
Participants in the autologous FMT-group will will receive an FMT with their own microbiota to account for the effects of the intervention itself. Participants in the "no intervention" group will not receive an FMT. Both control groups will be monitored and sampled identically to the allogenic FMT-group.
Outcome:
The primary outcome (MDRO-decolonization rate in treatment versus control) will be evaluated 1 month after FMT. Secondarily, safety and tolerability of the treatment will be assessed. The patients will be monitored up to 1 year after treatment to evaluate microbiome composition and to define parameters in the microbiome that are associated with clinical outcome.
- Conditions
- Resistance Bacterial
- Being tested
- Allogenic FMT, Autologous FMT
- Keywords
- Fecal Microbiota Transplantation, Hospitals, Isolation, Drug Resistance, Multiple, Bacterial, Gram-Negative Bacteria, Gastrointestinal Microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogenic FMTBiological
Also called Fecal Microbiota Transplantation with donor stool, Fecal Microbiota Transfer with donor stool
Transplantation of fecal microbiota from a donor into a recipient
Autologous FMTBiological
Also called Fecal Microbiota Transplantation with own stool, Fecal Microbiota Transfer with own stool
Transplantation of autologous fecal microbiota
| Study group | Role | What they receive |
|---|---|---|
| Allogenic FMT | Experimental | Participants in the allogenic FMT- group will receive FMT-treatment using healthy donor microbiota supplied by the Ghent Stool Bank. The donor stool (50g) is processed shortly after production and tested intensively. It's frozen at -80°C until administration via naso-duodenal/-jejunal tube (Cortrak). Receives: Biological: Allogenic FMT |
| Autologous FMT | Placebo comparator | Participants in the autologous FMT- group will receive FMT-treatment using their own microbiota to account for effects due to the treatment itself. Their stool is processed as close to the treatment as feasible. It's processed and frozen at -80°C until administration via naso-duodenal/-jejunal tube (Cortrak). Receives: Biological: Autologous FMT |
| No intervention | No intervention | Participants in the "No intervention"-group will not receive any treatment but will be monitored similarly as the "Allogenic FMT" and "Autologous FMT" groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with decolonization success/failure
These participants were screened positive for MDRO's in stool cultures before treatment and monitored at least once per week up to 1 month after treatment. "Decolonization" = 3 consecutive negative cultures in minimal time span of 2 weeks.
Measured: 1 month after treatment
Secondary outcomes (3)
Side effects
Monitor adverse events
Measured: up to 1 year after treatment
Treatment effect on microbial community in participants
Evaluation of gut bacterial composition changes in participants over time pre- and post-treatment with 16S ribosomal ribonucleic acid based metagenomic analysis.
Measured: up to 1 year after treatment
Treatment tolerability
The tolerability of the treatment is monitored with an in-house developed questionnaire considering the participant's opinion before, during and after the treatment on a score of 1 (very bad) to 5 (very good).
Measured: 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start18 Dec 2019
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance BacterialStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 150 participants will be randomly allocated to an "intervention" group (100p) and a "no intervention" group (50p). Participants in the "intervention" group will be randomised (double blind) to either fecal microbiota transfer with donor stool (allogenic FMT) or fecal microbiota transfer with own stool (autologous FMT). Participants in the "no intervention" group will be monitored without receiving a fecal microbiota transfer.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
- Investigators
- Bruno Verhasselt, Prof. Dr., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188743
- Sponsor's protocol ID
- BC-3034
- Other IDs
- 2018/0966
- Acronym
- DEKODON
- Status last verified
- Sep 2024
- First submitted
- 17 Oct 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data will be pseudonymized, not traceable to participant identity except for clinical staff. All participant data, questionnaires, colonization and sequencing data annotation will be collected in "open REDCap" (TLS encrypted secure web platform) to ensure traceability and safekeeping of the data. Data is stored and backed-up for at least 20 years on a secured server. Following data will be shared with other researchers: * baseline characteristics (age, BMI, sex...) * colonization status * analyzed gut microbial sequencing data * clinical follow-up data
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEKODON: Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)
- ClinicalTrials.gov ID
- NCT04188743
- Acronym / sponsor ID
- DEKODON / BC-3034
- Conditions
- Resistance Bacterial
- Keywords
- Fecal Microbiota Transplantation, Hospitals, Isolation, Drug Resistance, Multiple, Bacterial, Gram-Negative Bacteria, Gastrointestinal Microbiome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 6 Dec 2019 (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.
Colonization by Multiple Drug Resistant Organisms (MDROs) during patient hospitalization requires expensive isolation measures and renders the return or transfer to other departments or institutions often impossible. Currently there is no specific treatment available. Patients have to wait for spontaneous clearance which can take months or does not happen at all.
The study will test the effect of Fecal Microbiota Transfer (FMT) on gut MDRO colonization. The focus will be on patients with a long-term colonization by Gram-negative bacteria for which isolation is warranted. Participants will be randomized into two treatment groups; allogenic FMT versus autologous FMT. A third group of participants will be monitored but will not receive an FMT. Decolonization rate will be compared one month after treatment. Additionally gut microbial composition will be studied up to one year after FMT.
Detailed description
This double-blind controlled randomized study will test the efficacy of Fecal Microbiota Transfer (FMT) on gut Multiple Drug Resistant Organism (MDRO) colonization.
Participants:
The study targets hospitalized patients (>18 years old) that need to stay in isolation because of colonization by Carbapenem-resistant Enterobacteriales (CRE), non-E. coli Enterobacteriales that produce extended spectrum beta-lactamase (ESBL) or Multi Drug Resistant (MDR) Pseudomonas and MDR Acinetobacter species. Participants will be randomized in two groups (allogenic and autologous FMT). Additionally a third group of participants will be monitored without intervention.
Treatment:
Participants in the allogenic FMT- group will receive treatment using healthy donor microbiota preferably through naso-duodenal/-jejunal administration (Cortrak). Donor material will be supplied by the Ghent Stool Bank. The colonization status will be monitored on a regular basis (at least once per week) by culturing fecal swabs. Additionally fecal samples will be taken on fixed time points for microbial composition analysis (16S ribosomal ribonucleic acid metagenomics).
Controls:
Participants in the autologous FMT-group will will receive an FMT with their own microbiota to account for the effects of the intervention itself. Participants in the "no intervention" group will not receive an FMT. Both control groups will be monitored and sampled identically to the allogenic FMT-group.
Outcome:
The primary outcome (MDRO-decolonization rate in treatment versus control) will be evaluated 1 month after FMT. Secondarily, safety and tolerability of the treatment will be assessed. The patients will be monitored up to 1 year after treatment to evaluate microbiome composition and to define parameters in the microbiome that are associated with clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 150 participants will be randomly allocated to an "intervention" group (100p) and a "no intervention" group (50p). Participants in the "intervention" group will be randomised (double blind) to either fecal microbiota transfer with donor stool (allogenic FMT) or fecal microbiota transfer with own stool (autologous FMT). Participants in the "no intervention" group will be monitored without receiving a fecal microbiota transfer.
| Arm | Type | Receives |
|---|---|---|
| Allogenic FMT | Experimental | Biological: Allogenic FMTParticipants in the allogenic FMT- group will receive FMT-treatment using healthy donor microbiota supplied by the Ghent Stool Bank. The donor stool (50g) is processed shortly after production and tested intensively. It's frozen at -80°C until administration via naso-duodenal/-jejunal tube (Cortrak). |
| Autologous FMT | Placebo comparator | Biological: Autologous FMTParticipants in the autologous FMT- group will receive FMT-treatment using their own microbiota to account for effects due to the treatment itself. Their stool is processed as close to the treatment as feasible. It's processed and frozen at -80°C until administration via naso-duodenal/-jejunal tube (Cortrak). |
| No intervention | No intervention | –Participants in the "No intervention"-group will not receive any treatment but will be monitored similarly as the "Allogenic FMT" and "Autologous FMT" groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be at least 18 years of age, and must sign the 'informed consent' form and thus agree with the data collection, sampling and FMT.
- At least 2 consecutive confirmations of MDRO colonization in faeces, which complicate the necessary follow-up and/or therapy for the patient.
- Participants must be able to endure the treatment (evaluated by treating physician).
Key exclusion criteria (10 listed)
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis ...)
- Diagnosed hereditary blood disease (Haemophilia, Von Willebrand ...)
- Chronic liver disease
- Active drug use or alcohol abuse / dependence, which according to the researchers' opinion may interfere with the patient's participation in the study
- Simultaneous use of probiotics (except yoghurt)
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 |
|---|---|---|
| Allogenic FMTAlso: Fecal Microbiota Transplantation with donor stool, Fecal Microbiota Transfer with donor stoolTransplantation of fecal microbiota from a donor into a recipient | Biological | Allogenic FMT |
| Autologous FMTAlso: Fecal Microbiota Transplantation with own stool, Fecal Microbiota Transfer with own stoolTransplantation of autologous fecal microbiota | Biological | Autologous FMT |
Primary outcome
Number of participants with decolonization success/failure
Time frame: 1 month after treatment
These participants were screened positive for MDRO's in stool cultures before treatment and monitored at least once per week up to 1 month after treatment. "Decolonization" = 3 consecutive negative cultures in minimal time span of 2 weeks.
3 secondary outcomes
Side effects
Time frame: up to 1 year after treatment
Treatment effect on microbial community in participants
Time frame: up to 1 year after treatment
Treatment tolerability
Time frame: 1 month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. Participant data will be pseudonymized, not traceable to participant identity except for clinical staff. All participant data, questionnaires, colonization and sequencing data annotation will be collected in "open REDCap" (TLS encrypted secure web platform) to ensure traceability and safekeeping of the data. Data is stored and backed-up for at least 20 years on a secured server. Following data will be shared with other researchers: * baseline characteristics (age, BMI, sex...) * colonization status * analyzed gut microbial sequencing data * clinical follow-up data
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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.
Bruno Verhasselt, Prof. Dr. principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Allogenic FMT and Autologous FMT in people with Resistance Bacterial, run by University Hospital, Ghent at 1 site in Belgium.
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 10 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Belgium. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Verhasselt, Prof. Dr. (+3293322226, bruno.verhasselt@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with decolonization success/failure (time frame: 1 month after treatment). 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 19 Sep 2024.