Actively Recruiting
Multicenter, Randomized, Open-label Study Comparing Fecal Microbiota Transplantation, Probiotic Therapy, and Eubiotic Diet for Antibiotic-Resistant Bacteria Decolonization in Colonized Patients
Led by Medical University of Warsaw · Updated on 2025-09-03
360
Participants Needed
1
Research Sites
12 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
This research investigates three different approaches to remove antibiotic-resistant bacteria (ARB) from the gut of adult patients who are colonized with these bacteria. Researchers aim to compare fecal microbiota transplantation (FMT) after antibiotic pre-treatment, probiotic therapy, and a specially designed diet that promotes healthy gut bacteria. The study addresses a global health concern about antibiotic resistance highlighted by the World Health Organization and seeks to find new ways to reduce this risk. Participants are randomly assigned to one of three groups: the FMT group receives antibiotics followed by bowel cleansing and then FMT either by capsules or colonoscopy; the probiotic group undergoes bowel cleansing then takes a high-dose probiotic twice daily for 20 days; and the diet group follows a 38-day meal plan designed to support healthy gut bacteria. The FMT group is hospitalized during treatment, while the other groups are treated as outpatients. Throughout the study, participants have visits for screening, treatment start, and follow-ups up to six months after treatment to check safety and effectiveness. Tests include medical exams and collecting stool, urine, saliva, and blood samples to monitor bacterial colonization and changes. The main measurement is complete removal of antibiotic-resistant bacteria in the gut 60 days after treatment. Longer-term outcomes are also evaluated at 30, 90, and 180 days post-treatment.
CONDITIONS
Brief 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 tests
- Colonization by carbapenem-resistant strains, multidrug-resistant Enterobacteriaceae, VRE, or MRSA
- Absolute neutrophil count (ANC) above 500/µL prior to FMT or as required before each FMT
- Estimated life expectancy of at least 12 months
- Ability to swallow large capsules or no contraindications to colonoscopy
- No history of anaphylactic shock to foods and ability to tolerate probiotics
- Provided written informed consent to participate
You will not qualify if you...
- Lack of consent or inability to provide informed consent
- Absolute neutrophil count (ANC) below 500 cells/µL or expected to decline below this
- HIV infection with CD4 count below 250 cells/µL
- Active infection requiring antibiotics on FMT day or planned antibiotics within 7 days after
- Gastrointestinal mucosal damage posing risk of adverse events
- Contraindications to FMT via gastrointestinal routes
- Inability to undergo preparatory antibiotic or bowel cleansing therapy
- Inability to swallow large capsules or contraindications to colonoscopy
- Severe food allergy with anaphylactic history or intolerance to probiotics
- Pregnancy or breastfeeding
- Severe medical conditions preventing study adherence
- Participation in another clinical trial with investigational drug/device within 3 months
- Inability or unwillingness to comply with protocol requirements
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 38 days depending on intervention
Participants receive one of three interventions to decolonize antibiotic-resistant bacteria: Fecal Microbiota Transplantation (FMT) after antibiotic pre-treatment and bowel cleansing, probiotic therapy following bowel cleansing, or a gut microbiota boosting diet after bowel cleansing.
1 to 2 visits during treatment initiation plus daily or periodic visits depending on the assigned intervention
Duration - Up to 6 months post-intervention
Participants are monitored for safety, efficacy, and long-term outcomes including decolonization of antibiotic-resistant bacteria.
Multiple follow-up visits over 6 months
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.
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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