Using fecal microbiota transplantation to eliminate antibiotic-resistant bacteria
Fecal Microbiota Transplantation to Eradicate Antibiotic-resistance Bacteria From the Gastrointestinal Tract of Patients at High Risk of Infection and/or to Cut Off the Spread of Bacteria With Dangerous Mechanisms of Antibiotic Resistance
This study is testing whether a new way of using fecal microbiota transplantation can help people with antibiotic-resistant bacteria in their gut feel better and reduce their risk of infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | Human Biome Institute S.A. Industry-sponsored |
| Locations | 5 sites (Gdańsk and 4 other locations) |
| Trial ID | NCT06156956 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new protocol for fecal microbiota transplantation (FMT) aimed at eradicating antibiotic-resistant bacteria (ARB) from the gastrointestinal tract. It focuses on patients colonized with ARB, assessing the safety and efficacy of FMT in improving gut microbiome diversity and reducing infection risk. The intervention involves administering FMT in capsules or via colonoscopy, with treatments scheduled on specific days following the initiation of the procedure. The study aims to determine if this approach can enhance patient prognosis and quality of life.
Who should consider this trial
Good fit: Ideal candidates include individuals over 6 months old who are colonized with specific strains of antibiotic-resistant bacteria.
Not a fit: Patients who are not colonized with antibiotic-resistant bacteria or those with other unrelated health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the prevalence of antibiotic-resistant infections in vulnerable patients.
How similar studies have performed: Previous studies have shown that fecal microbiota transplantation can effectively treat certain infections, suggesting potential success for this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gdańsk and 4 other locations
- Uniwersyteckie Centrum Kliniczne, Klinika Gastroenterologii i Hepatologii — Gdańsk, Poland (Recruiting)
- Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii — Gdańsk, Poland (Recruiting)
- Uniwersyteckie Centrum Kliniczne, Klinika Pediatrii, Hematologii i Onkologii — Gdańsk, Poland (Recruiting)
- WOJEWÓDZKI SZPITAL ZESPOLONY W KIELCACH, Klinika Chorób Zakaźnych — Kielce, Poland (Recruiting)
- WIM-PIB: Klinika Chorób Infekcyjnych i Alergologii, Klinika Gastroenterologii i Chorób Wewnętrznych — Warszawa, Poland (Recruiting)
Study contacts
- Principal investigator: Jaroslaw Bilinski, MD, PhD — Human Biome Institute S.A.
- Study coordinator: Jaroslaw Bilinski, MD, PhD
- Email: jaroslaw.bilinski@human-biome.com
- Phone: 884 299 668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.