Fecal Microbiota Transplantation (FMT) to Decolonize Antibiotic - Resistant Bacteria (ARB) - New Protocol

Launched by HUMAN BIOME INSTITUTE S.A. · Dec 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called fecal microbiota transplantation (FMT) to see if it can help eliminate antibiotic-resistant bacteria (ARB) from patients. Antibiotic-resistant bacteria are germs that do not respond to standard antibiotics, making infections harder to treat. The goal of this study is to find out if this new FMT approach can safely and effectively reduce these bacteria in patients, and if it can also improve their overall health and quality of life.

To participate in this trial, individuals must be at least 6 months old and have been diagnosed with antibiotic-resistant bacteria. Participants will need to provide consent and meet certain health requirements, such as having a specific level of white blood cells in their blood. Those who are currently facing serious infections or have certain medical conditions may not be eligible. If chosen for the trial, participants can expect to receive the FMT treatment, which involves transferring healthy bacteria from a donor's stool to help restore a balanced gut environment and potentially fight off the resistant bacteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \> 6 months
• 2. Population of patients colonized with antibiotic-resistant bacteria, as follows:
• • 1. strains of antibiotic-resistant bacteria that exhibit resistance mechanisms to carbapenems (MBL+: NDM+, VIM+ or others), KPC+, OXA-48+ or confirmed resistance to carbapenems without a specific genetic mechanism
• • 2. strains of Enterobacteriaceae resistant to beta lactams and other antibiotics in the case of multi-drug resistance (e.g. in the ESBL resistance mechanism and others) of the types including Escherichia, Enterobacter, Klebsiella, strains of P. aeruginosa, A. baumannii (together included in, among others, the ESKAPE group)
• • 3. Gram (+) enterococci E. faecalis or E. faecium or other bacteria resistant to vancomycin (VRE), linezolid and strains of S. aureus resistant to methicillin (MRSA) or vancomycin
• • 4. other multidrug-resistant or drug-resistant strains with threatening clinical resistance mechanisms or in patients vulnerable to infection with a particular pathogen
• • 3. Absolute neutrophil count in the peripheral blood up to 3 days before FMT \> 500/ul (in the case of tandem multiple FMTs, in patients with an expected decrease in neutrophil values, the test should be repeated before each FMT when the timeframe between FMTs is longer than 3 days, and in patients without an expected decrease in the value of neutrophils below 500 cells/ul peripheral blood counts are valid for 28 days)
• • 4. Signing of the informed consent for participation in the study.
• Exclusion Criteria:
• • 1. Inability to obtain informed consent and lack of consent
• • 2. Blood neutrophil count \<500/uL on the day of fecal microbiota transplantation or expected decrease to the mentioned number within 2 consecutive days
• • 3. Active infection requiring intensive antimicrobial treatment on FMT day or the first 7 days after FMT in immunocompetent patients (without immunosuppression or immunodeficiency)
• • 4. Clinical signs of mucositis 7 days prior to FMT
• • 5. Contraindications to FMT via upper and lower gastrointestinal tract (e.g. perforation of the digestive tract, rectal atresia, discontinuity of the digestive tract and others)
• • 6. Severe food allergy with the anaphylaxis history