NCT07094984 Comparison of Three Interventions for Antibiotic-Resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract
| NCT ID | NCT07094984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Warsaw |
| Condition | Drug Resistance, Bacterial |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2024-12-31 |
| Primary Completion | 2027-02-01 |
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.
This trial targets 360 participants in total. It began in 2024-12-31 with a primary completion date of 2027-02-01.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years; * Documented intestinal colonization with antibiotic-resistant bacteria confirmed by at least two positive cultures (rectal swabs or, alternatively, stool cultures), with the last positive result obtained at least 28 days prior to the planned procedure; * Documented colonization by one or more of the following bacterial strains: 1. Carbapenem-resistant strains with confirmed resistance mechanisms, including MBL+ (NDM+, VIM+, or others), KPC+, OXA-48+, or phenotypic carbapenem resistance without identified genetic mechanism; 2. Multidrug-resistant Enterobacteriaceae resistant to beta-lactams and other antibiotics, especially ESBL-producing strains, including Escherichia, Enterobacter, Klebsiella spp., and/or P. aeruginosa, A. baumannii (commonly associated with the ESKAPE group); 3. Gram-positive bacteria such as Enterococcus faecalis, Enterococcus faecium, or other vancomycin-resistant enterococci (VRE), as well as Staphylococcus aureus strains resistant to methicillin (MRSA) and/or vancomycin; * Absolute neutrophil count (ANC) in peripheral blood \>500/μL within 3 days prior to FMT; In case of tandem or repeated FMTs and expected neutrophil decline, the ANC test should be repeated before each FMT if the interval exceeds 3 days. For patients without expected neutropenia (\<500/μL), the blood count remains valid for 28 days; * Estimated life expectancy of at least 12 months; * Ability to swallow large capsules (confirmed using a test capsule) or absence of contraindications to colonoscopy; * No history of anaphylactic shock due to food allergies and ability to tolerate probiotic supplementation; * Provision of written informed consent to participate in the study. Exclusion Criteria: * Lack of consent to participate in the study or inability to establish logical contact and obtain consent from an authorized representative; * Absolute neutrophil count (ANC) \< 500 cells/μL on the day of FMT (within 3 days prior) or predicted decline to this level within the next 2 days; * Diagnosed HIV infection with CD4 lymphocyte count \< 250 cells/μL; * Active infection requiring antibiotic therapy on the day of FMT or planned antibiotic use during the first 7 days following FMT; * Symptoms or radiological/endoscopic evidence of gastrointestinal mucosal damage within 7 days prior to FMT (e.g., ulceration, perforation, gastrointestinal bleeding) posing a risk of serious adverse events; * Contraindications for FMT administration via upper or lower gastrointestinal tract routes (e.g., gastrointestinal perforation, anal atresia, lack of intestinal continuity, or other); * Inability to undergo preparatory therapy (oral antibiotics: colistin, vancomycin, gentamicin and/or bowel cleansing agents) prior to FMT; * Inability to swallow large capsules (confirmed with test capsules) or contraindications for colonoscopy; * Severe food allergy with history of anaphylactic shock or inability to tolerate probiotics; * Pregnancy or breastfeeding; * Severe medical conditions contraindicating study protocol adherence as determined by the treating physician (e.g., severe heart failure precluding bowel cleansing due to risk of fluid overload or dehydration); * Participation in another clinical trial and administration of an investigational drug or device within 3 months prior to randomization; * Reluctance or inability to comply with protocol requirements, including any physical, mental, or social condition that may impair the participant's ability to adhere to the protocol.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07094984 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Drug Resistance, Bacterial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07094984 currently recruiting?
Yes, NCT07094984 is actively recruiting participants. Contact the research team at jaroslaw.bilinski@human-biome.com for enrollment information.
Where is the NCT07094984 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT07094984 clinical trial?
NCT07094984 is sponsored by Medical University of Warsaw. The trial plans to enroll 360 participants.