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New treatment option for Drug Resistance, Bacterial
Official title Comparison of Three Interventions for Antibiotic-Resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract
ClinicalTrials.gov ID: NCT07094984
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years;
- Documented intestinal colonization with antibiotic-resistant bacteria confirmed by at least two positive cultures (rectal swabs or, alternatively...
- 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...
- Multidrug-resistant Enterobacteriaceae resistant to beta-lactams and other antibiotics, especially ESBL-producing strains, including Escherichia...
You likely can't join if
- 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...
- Contraindications for FMT administration via upper or lower gastrointestinal tract routes (e.g., gastrointestinal perforation, anal atresia, lack of...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.