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

NCT06156956 | Unknown

• 1 other identifier: HBI/2023/01/STOP-ARB2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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. 1.Will new treatment protocol and fully anaerobic FMT be effective in decolonization of ARB?
2. 2.Will FMT improve the prognosis and quality of life in patients at high risk of ARB infection?

Conditions

Drug Resistance, Bacterial; Antimicrobial Drug Resistance

Keywords

Antibiotic-resistant bacteria decolonization; Gastrointestinal tract colonization; Eradication procedure; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• Eradication of gut colonizing antibiotic-resistant bacteria

  The effectiveness of the therapy is assessed by means of rectal swabs and/or stool cultures after 30, 60, 90, 180 and 360 days (i.e. after a month, two, three and six) from the end of the eradication procedure

  Baseline, 30, 60, 90, 180, 360 days after the end of eradication

Secondary Outcomes (1)

• Increase in the diversity of the recipients' gut microbiota

  from pre-treatment to 360 days after-treatment

Other Outcomes (1)

• Infections-oriented safety profile assessment

  During 3 months form FMT

Study Arms (1)

Fecal Microbiota Transplantation

EXPERIMENTAL

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).

Procedure: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation PROCEDURE

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

Also known as: MBiotix HBI

Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 6 months
• Population of patients colonized with antibiotic-resistant bacteria, as follows:
• 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
• 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)
• 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
• other multidrug-resistant or drug-resistant strains with threatening clinical resistance mechanisms or in patients vulnerable to infection with a particular pathogen
• 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)
• Signing of the informed consent for participation in the study.

You may not qualify if:

• Inability to obtain informed consent and lack of consent
• Blood neutrophil count \<500/uL on the day of fecal microbiota transplantation or expected decrease to the mentioned number within 2 consecutive days
• Active infection requiring intensive antimicrobial treatment on FMT day or the first 7 days after FMT in immunocompetent patients (without immunosuppression or immunodeficiency)
• Clinical signs of mucositis 7 days prior to FMT
• 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)
• Severe food allergy with the anaphylaxis history

Sponsors & Collaborators

• Human Biome Institute S.A.: lead

Study Sites (5)

Uniwersyteckie Centrum Kliniczne, Klinika Gastroenterologii i Hepatologii

Gdansk, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

Gdansk, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne, Klinika Pediatrii, Hematologii i Onkologii

Gdansk, 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

Warsaw, Poland

RECRUITING

Related Publications (8)

• 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.

  PMID: 31662862 BACKGROUND

• 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.

  PMID: 29555994 BACKGROUND

• 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.

  PMID: 22726443 BACKGROUND

• 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.

  PMID: 24096337 BACKGROUND

• 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.

  PMID: 23334413 BACKGROUND

• 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.

  PMID: 28369341 BACKGROUND

• 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.

  PMID: 25982290 BACKGROUND

• 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.

  PMID: 25041704 BACKGROUND

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Jaroslaw Bilinski, MD, PhD

  Human Biome Institute S.A.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaroslaw Bilinski, MD, PhD

CONTACT

884 299 668; jaroslaw.bilinski@human-biome.com

Dorota Makarewicz, PhD

CONTACT

884 299 668; dorota.makarewicz@human-biome.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group, open label, observational study with intervention (Fecal Microbiota Transplantation)

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: December 5, 2023
• Study Start: October 27, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5)