BridgeMD
New treatment option for Resistance Bacterial
Official title Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)
ClinicalTrials.gov ID: NCT04188743
What this study is testing
What is Allogenic FMT?
Allogenic FMT is an investigational medicine, being studied as a potential treatment for resistance bacterial.
Also referred to as Fecal Microbiota Transplantation with donor stool, Fecal Microbiota Transfer with donor stool.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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).
You likely can't join if
- 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...
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Oost-Vlaanderen, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Oost-Vlaanderen, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.