Actively Recruiting
Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)
Led by University Hospital, Ghent · Updated on 2024-09-19
150
Participants Needed
1
Research Sites
314 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
R
Research Foundation Flanders
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years of age and provide informed consent for data collection, sampling, and FMT.
- Must have at least 2 consecutive confirmations of MDRO colonization in feces complicating follow-up or therapy.
- Must be evaluated by the treating physician as able to endure the treatment.
You will not qualify if you...
- Inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
- Diagnosed hereditary blood diseases like Haemophilia or Von Willebrand.
- Chronic liver disease.
- Active drug use or alcohol abuse/dependence that may interfere with participation.
- Use of probiotics other than yoghurt.
- Existing immune deficiency or immunomodulatory treatment within 12 weeks prior to randomization, except nasal or inhaled corticosteroids.
- Positive pregnancy test or potential pregnancy.
- Breastfeeding.
- Severe food allergy including anaphylaxis or urticarial.
- Antibiotic treatment within 7 days before FMT or planned within one month after FMT.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
Research Team
B
Bruno Verhasselt, Prof. Dr.
CONTACT
H
Hannelore Hamerlinck, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here