Actively Recruiting
Comparison of Three Interventions for Antibiotic-Resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract
Led by Medical University of Warsaw · Updated on 2025-09-03
360
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
M
Medical University of Warsaw
Lead Sponsor
H
Human Biome Institute S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this research experiment is to evaluate the effectiveness of fecal microbiota transplantation (FMT) preceded by antibiotic pre-treatment versus probiotic therapy and a standard-of-care equivalent diet designed to stimulate the growth of eubiotic gut microbiota (an active comparator enhancing the ethical value of the study and increasing the chances of spontaneous decolonization of antibiotic-resistant bacteria (ARB) in the absence of any active intervention recommended by Scientific Societies) in the decolonization of bacteria with the most clinically significant antibiotic resistance mechanisms from the gastrointestinal tract of colonized patients. This study addresses the urgent need highlighted by the World Health Organization (WHO) for new strategies to combat antibiotic resistance, aiming to prevent its progression into a global pandemic that could undermine the achievements of modern civilization. Study Hypotheses: * The decolonization rate of ARB bacteria in patients undergoing the intervention (FMT or probiotic therapy) is the same as in patients treated with standard-of-care (SoC) alone. * The decolonization rate of ARB bacteria in the intervention groups (FMT or probiotic therapy) is at least 20 percentage points higher than in patients treated with the standard approach (diet). The findings from this study may contribute to developing innovative microbiota-based therapies for the decolonization of antibiotic-resistant bacteria and help reduce the global burden of antibiotic resistance.
CONDITIONS
Official Title
Comparison of Three Interventions for Antibiotic-Resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed intestinal colonization with antibiotic-resistant bacteria by at least two positive cultures, with the last positive result at least 28 days before the planned procedure
- Colonization by carbapenem-resistant strains, multidrug-resistant Enterobacteriaceae, vancomycin-resistant enterococci, or methicillin-resistant Staphylococcus aureus
- Absolute neutrophil count above 500/µL within 3 days prior to FMT; repeat testing before each FMT if intervals exceed 3 days
- Estimated life expectancy of at least 12 months
- Ability to swallow large capsules or no contraindications for colonoscopy
- No history of anaphylactic shock due to food allergies and ability to tolerate probiotic supplements
- Provided written informed consent to participate
You will not qualify if you...
- Lack of consent or inability to provide informed consent
- Absolute neutrophil count below 500 cells/µL on the day of FMT or expected drop within 2 days
- Diagnosed HIV infection with CD4 count below 250 cells/µL
- Active infection requiring antibiotics on the day of FMT or planned antibiotic use within 7 days after FMT
- Gastrointestinal mucosal damage within 7 days prior to FMT (e.g., ulceration, perforation, bleeding)
- Contraindications for FMT administration by gastrointestinal routes
- Inability to undergo preparatory antibiotic or bowel cleansing therapy before FMT
- Inability to swallow large capsules or contraindications for colonoscopy
- Severe food allergy with history of anaphylactic shock or inability to tolerate probiotics
- Pregnancy or breastfeeding
- Severe medical conditions preventing protocol adherence
- Participation in another clinical trial with investigational drug/device within 3 months prior to randomization
- Inability or unwillingness to comply with protocol requirements or conditions impairing adherence
AI-Screening
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Trial Site Locations
Total: 1 location
1
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Klinika Hematologii, Transplantologii i Chorób Wewnętrznych
Warsaw, Poland
Actively Recruiting
Research Team
J
Jaroslaw Bilinski, MD PhD, Assoc. Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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