NCT04188743 Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)
| NCT ID | NCT04188743 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University Hospital, Ghent |
| Condition | Resistance Bacterial |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2019-12-18 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2019-12-18 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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 * 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.
Contact & Investigator
Bruno Verhasselt, Prof. Dr.
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT04188743 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Resistance Bacterial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04188743 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04188743 currently recruiting?
Yes, NCT04188743 is actively recruiting participants. Contact the research team at bruno.verhasselt@uzgent.be for enrollment information.
Where is the NCT04188743 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT04188743 clinical trial?
NCT04188743 is sponsored by University Hospital, Ghent. The principal investigator is Bruno Verhasselt, Prof. Dr. at University Hospital, Ghent. The trial plans to enroll 150 participants.