Fecal Microbiota Transplantation (FMT) to Decolonize Antibiotic - Resistant Bacteria (ARB) - New Protocol
NCT ID: NCT06156956
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-10-27
2025-12-31
Brief Summary
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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?
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fecal Microbiota Transplantation
Antibiotics pre-treatment on days 1-5 and a bowel cleansing on day 6. Days 7-14 are dedicated to active eradication treatment with FMT. First dose on day 7 and second dose in days 9-14 (1/6 of full dose every day).
Fecal Microbiota Transplantation
Fecal Microbiota Transplantation in capsules or suspension obtained from healthy unrelated donor introduced two times per treatment:
for capsules - FMT administration: day 7 (full dose) and days from 9 to 14 (prolonged intake regimen)
for suspension - FMT administration: day 7 and day 14
Interventions
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Fecal Microbiota Transplantation
Fecal Microbiota Transplantation in capsules or suspension obtained from healthy unrelated donor introduced two times per treatment:
for capsules - FMT administration: day 7 (full dose) and days from 9 to 14 (prolonged intake regimen)
for suspension - FMT administration: day 7 and day 14
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
6 Months
ALL
No
Sponsors
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Human Biome Institute S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Jaroslaw Bilinski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Human Biome Institute S.A.
Locations
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Uniwersyteckie Centrum Kliniczne, Klinika Gastroenterologii i Hepatologii
Gdansk, , Poland
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk, , Poland
Uniwersyteckie Centrum Kliniczne, Klinika Pediatrii, Hematologii i Onkologii
Gdansk, , Poland
WOJEWÓDZKI SZPITAL ZESPOLONY W KIELCACH, Klinika Chorób Zakaźnych
Kielce, , Poland
WIM-PIB: Klinika Chorób Infekcyjnych i Alergologii, Klinika Gastroenterologii i Chorób Wewnętrznych
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Krystian Adrych
Role: primary
Anna Irga-Staniukiewicz
Role: primary
Ninela Irga-Jaworska
Role: primary
Paweł Pabjan
Role: primary
Krzysztof Kłos
Role: primary
References
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Rokkas T, Gisbert JP, Gasbarrini A, Hold GL, Tilg H, Malfertheiner P, Megraud F, O'Morain C. A network meta-analysis of randomized controlled trials exploring the role of fecal microbiota transplantation in recurrent Clostridium difficile infection. United European Gastroenterol J. 2019 Oct;7(8):1051-1063. doi: 10.1177/2050640619854587. Epub 2019 May 27.
Maier L, Pruteanu M, Kuhn M, Zeller G, Telzerow A, Anderson EE, Brochado AR, Fernandez KC, Dose H, Mori H, Patil KR, Bork P, Typas A. Extensive impact of non-antibiotic drugs on human gut bacteria. Nature. 2018 Mar 29;555(7698):623-628. doi: 10.1038/nature25979. Epub 2018 Mar 19.
Chung H, Pamp SJ, Hill JA, Surana NK, Edelman SM, Troy EB, Reading NC, Villablanca EJ, Wang S, Mora JR, Umesaki Y, Mathis D, Benoist C, Relman DA, Kasper DL. Gut immune maturation depends on colonization with a host-specific microbiota. Cell. 2012 Jun 22;149(7):1578-93. doi: 10.1016/j.cell.2012.04.037.
Buffie CG, Pamer EG. Microbiota-mediated colonization resistance against intestinal pathogens. Nat Rev Immunol. 2013 Nov;13(11):790-801. doi: 10.1038/nri3535. Epub 2013 Oct 7.
Diehl GE, Longman RS, Zhang JX, Breart B, Galan C, Cuesta A, Schwab SR, Littman DR. Microbiota restricts trafficking of bacteria to mesenteric lymph nodes by CX(3)CR1(hi) cells. Nature. 2013 Feb 7;494(7435):116-20. doi: 10.1038/nature11809. Epub 2013 Jan 13.
Bilinski J, Grzesiowski P, Sorensen N, Madry K, Muszynski J, Robak K, Wroblewska M, Dzieciatkowski T, Dulny G, Dwilewicz-Trojaczek J, Wiktor-Jedrzejczak W, Basak GW. Fecal Microbiota Transplantation in Patients With Blood Disorders Inhibits Gut Colonization With Antibiotic-Resistant Bacteria: Results of a Prospective, Single-Center Study. Clin Infect Dis. 2017 Aug 1;65(3):364-370. doi: 10.1093/cid/cix252.
Kelly CR, Kahn S, Kashyap P, Laine L, Rubin D, Atreja A, Moore T, Wu G. Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook. Gastroenterology. 2015 Jul;149(1):223-37. doi: 10.1053/j.gastro.2015.05.008. Epub 2015 May 15.
Kronman MP, Zerr DM, Qin X, Englund J, Cornell C, Sanders JE, Myers J, Rayar J, Berry JE, Adler AL, Weissman SJ. Intestinal decontamination of multidrug-resistant Klebsiella pneumoniae after recurrent infections in an immunocompromised host. Diagn Microbiol Infect Dis. 2014 Sep;80(1):87-9. doi: 10.1016/j.diagmicrobio.2014.06.006. Epub 2014 Jun 21.
Other Identifiers
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HBI/2023/01/STOP-ARB2
Identifier Type: -
Identifier Source: org_study_id