Comparison of Three Interventions for Antibiotic-Resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract

Plain-language summary

This study compares three approaches, fecal microbiota transplantation, probiotic therapy, and a gut-microbiota-boosting diet, for clearing antibiotic-resistant bacteria from the intestines of people who carry them. It is open to people aged 18 and older whose intestinal colonization is confirmed by at least two positive cultures. It is a study without an assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Medical University of Warsaw

Intervention

Fecal microbiota transplantation (FMT), Probiotic Therapy, Gut Microbiota Boosting Diet

Start date

12/31/2024

Estimated completion

4/30/2027

Countries

Poland

Related genes

Locations

• Warsaw, Poland

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.