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

Last updated: December 1, 2023
Sponsor: Human Biome Institute S.A.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Fecal Microbiota Transplantation

Clinical Study ID

NCT06156956
HBI/2023/01/STOP-ARB2
  • Ages > 6
  • All Genders

Study Summary

The aim of the study is to assess the safety and efficacy of new protocol fecal microbiota transplantation (FMT) in the eradication of antibiotic resistant bacteria, including those featuring of resistance to new generation antibiotics.

This study should answer the following research questions:

  1. Will new treatment protocol and fully anaerobic FMT be effective in decolonization of ARB?

  2. Will FMT improve the prognosis and quality of life in patients at high risk of ARB infection?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age > 6 months
  2. Population of patients colonized with antibiotic-resistant bacteria, as follows:
  3. strains of antibiotic-resistant bacteria that exhibit resistance mechanisms tocarbapenems (MBL+: NDM+, VIM+ or others), KPC+, OXA-48+ or confirmed resistanceto carbapenems without a specific genetic mechanism
  4. strains of Enterobacteriaceae resistant to beta lactams and other antibiotics inthe case of multi-drug resistance (e.g. in the ESBL resistance mechanism andothers) of the types including Escherichia, Enterobacter, Klebsiella, strains ofP. aeruginosa, A. baumannii (together included in, among others, the ESKAPEgroup)
  5. Gram (+) enterococci E. faecalis or E. faecium or other bacteria resistant tovancomycin (VRE), linezolid and strains of S. aureus resistant to methicillin (MRSA) or vancomycin
  6. other multidrug-resistant or drug-resistant strains with threatening clinicalresistance mechanisms or in patients vulnerable to infection with a particularpathogen
  7. Absolute neutrophil count in the peripheral blood up to 3 days before FMT > 500/ul (inthe case of tandem multiple FMTs, in patients with an expected decrease in neutrophilvalues, the test should be repeated before each FMT when the timeframe between FMTs islonger than 3 days, and in patients without an expected decrease in the value ofneutrophils below 500 cells/ul peripheral blood counts are valid for 28 days)
  8. Signing of the informed consent for participation in the study.

Exclusion

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 orexpected decrease to the mentioned number within 2 consecutive days
  3. Active infection requiring intensive antimicrobial treatment on FMT day or the first 7days after FMT in immunocompetent patients (without immunosuppression orimmunodeficiency)
  4. Clinical signs of mucositis 7 days prior to FMT
  5. Contraindications to FMT via upper and lower gastrointestinal tract (e.g. perforationof the digestive tract, rectal atresia, discontinuity of the digestive tract andothers)
  6. Severe food allergy with the anaphylaxis history

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Fecal Microbiota Transplantation
Phase:
Study Start date:
October 27, 2023
Estimated Completion Date:
December 31, 2025

Study Description

Fecal microbiota transplantation (FMT) was shown to be very efficient in treatment of relapsed and refractory Clostridium difficile infection and became a standard treatment. The investigators company produces and uses FMT not only in case of Clostridioides difficile colitis, but also in case of gut colonization with antibiotic-resistant bacteria and other indications as a clinical studies under Bioethical Committee approval. Company's flagship program to decolonize ARB is based on assumption that physiological gut flora may outcompete the pathogenic bacteria similarly as in case of Clostridium difficile and lead to loss of colonization.

Patients colonized with ARB are characterized by poor diversity of gut microbiome (dysbiosis), which makes them vulnerable to further infections. In case of gut mucosa injury and severe immune suppression, these colonizing bacteria may cause severe systemic infections.

During this interventional prospective, single arm, observational study, the investigators collect the information about the safety and effectiveness of FMT in gut decolonization with antibiotic-resistance bacteria (ARB) using their new treatment protocol and own full-spectrum, full-richness, full-viability anaerobic FMT.

The project protocol is based on the intervention (fecal microbiota transplantation; FMT) in capsules (or colonoscopy if per os route is not possible) applied twice - on day 7th after procedure initiation and between day 9-14 within extended period, low dose (1/6th every day) application. All patient are premedicated with non-absorbable antibiotics on days 1-5 and a bowel cleansing on day 6 from the screening. After the end of the eradication procedure, the patient proceeds to the follow-up assessment stage and is observed up to 360 days with longitudinal samples collection.

Connect with a study center

  • Uniwersyteckie Centrum Kliniczne, Klinika Gastroenterologii i Hepatologii

    Gdańsk,
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

    Gdańsk,
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne, Klinika Pediatrii, Hematologii i Onkologii

    Gdańsk,
    Poland

    Active - Recruiting

  • WOJEWÓDZKI SZPITAL ZESPOLONY W KIELCACH, Klinika Chorób Zakaźnych

    Kielce,
    Poland

    Active - Recruiting

  • WIM-PIB: Klinika Chorób Infekcyjnych i Alergologii, Klinika Gastroenterologii i Chorób Wewnętrznych

    Warszawa,
    Poland

    Active - Recruiting

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