Badanie kliniczne: Drug Resistance
Tytuł w rejestrze: Comparison of Three Interventions for Antibiotic-Resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract
Najważniejsze informacje
- Choroba
- Drug Resistance, Bacterial, Antimicrobial Drug Resistance
- Status w Polsce
- Rekrutujestany polskich ośrodków według ClinicalTrials.gov
- Status na świecie
- Rekrutujestan całego badania w rejestrze
- Wiek uczestników
- od 18 lat
- Płeć
- kobiety i mężczyźni
- Planowana liczba uczestników
- łącznie 360
- Sponsor
- Medical University of Warsaw
- Terminy (planowane)
- 31 grudnia 2024 - 30 kwietnia 2027
- Kraje
- 1: Polska
- Numer w rejestrze
- NCT07094984 (ClinicalTrials.gov)
Gdzie prowadzone jest badanie
Ośrodki prowadzące badanie w Polsce (1), alfabetycznie według miejscowości:
- WarszawaKontakt
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Cel badania
Opis z rejestru (w języku angielskim):
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.
Leczenie w badaniu
| Lek / interwencja | Rola | Postać, podanie |
|---|---|---|
| Fecal microbiota transplantation (FMT) | Inne | |
| Probiotic Therapy | Suplement | |
| Gut Microbiota Boosting Diet | Inne |
Kryteria udziału
Kryteria w języku angielskim, tak jak w rejestrze.
Kryteria włączenia kto może wziąć udział (11)
- 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:
- Carbapenem-resistant strains with confirmed resistance mechanisms, including MBL+ (NDM+, VIM+, or others), KPC+, OXA-48+, or phenotypic carbapenem resistance without identified genetic mechanism;
- 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);
- 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.
Kryteria wyłączenia kto nie może wziąć udziału (13)
- 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.
To główne kryteria z rejestru. Pełną listę i ostateczną decyzję o udziale ustala lekarz prowadzący badanie.
Zapytaj o udział w tym badaniu
Zadzwoń, a nasz doradca ds. badań sprawdzi z Tobą wstępnie kryteria i pomoże skontaktować się z ośrodkiem. Kwalifikację zawsze przeprowadza lekarz w ośrodku. Udział w badaniu jest bezpłatny i dobrowolny.
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Informacje pochodzą z publicznych rejestrów badań klinicznych (CTIS - Unia Europejska, ClinicalTrials.gov - USA) i są aktualizowane codziennie. Mogą różnić się od aktualnego stanu w ośrodku. Ostateczną kwalifikację do badania zawsze przeprowadza lekarz w ośrodku badawczym. Stan na 2 października 2026.