Stool Transplantation to Reduce Antibiotic Resistance Transmission
NCT ID: NCT02461199
Last Updated: 2015-06-04
Study Results
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Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2015-02-28
2017-09-30
Brief Summary
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Patients with blood disorders are characterized by poor diversity of gut microbiome, affected by repeated chemotherapy and antimicrobial treatments. This makes them vulnerable to colonization by pathogenic bacteria carrying genes responsible for antibiotic resistance. In case of gut mucosa injury and severe immune suppression, these colonizing bacteria may cause severe systemic infections. As the bacteria are secreted with the stool, the colonized patients become an epidemiologic threat to the others.
Fecal microbiota transplantation (FMT) was shown to be very efficient in treatment of relapsed and refractory Clostridium difficile infection and became a standard treatment. In home institution, the investigators use FMT not only in case of Clostridium difficile colitis, but also in case of gut colonization with multidrug-resistant (MDR) bacteria. This 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. The procedure is performed in all patients colonized, who qualify according to listed inclusion and exclusion criteria .
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Fecal microbiota transplantation
Patients with proven gut colonization status with following bacteria: Klebsiella pneumoniae resistant to carbapenems, Pseudomonas aeruginosa resistant to carbapenems, Enterococcus faecalis VRE (vancomycin-resistant enterococcus), Enterococcus faecium VRE, Enterobacter cloacae resistant to carbapenems or other MDR species. Gut colonization proven by conventional microbiological culture and/or molecular methods.
Fecal microbiota transplantation
Transplantation of 100 ml of fecal microbiota suspension obtained from healthy unrelated donor in two consecutive days via the nasoduodenal tube
Interventions
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Fecal microbiota transplantation
Transplantation of 100 ml of fecal microbiota suspension obtained from healthy unrelated donor in two consecutive days via the nasoduodenal tube
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Carrier status of MDR bacteria in stool: Klebsiella pneumoniae resistant to carbapenems, Pseudomonas aeruginosa resistant to carbapenems, Enterococcus faecalis VRE, Enterococcus faecium VRE, Enterobacter cloacae KPC+ or other MDR species documented by at least two stool cultures
* Blood neutrophil count \> 500/uL on the day of fecal microbiota transplantation
Exclusion Criteria
* Blood neutrophil count \<500/uL on the day of fecal microbiota transplantation or expected decrease to the mentioned number within 2 consecutive days
* Intensive, myelosuppressive chemotherapy (e.g. DHAP, ICE, ESHAP, HD-Cy, HD-Ara-C, DA, conditioning before allogeneic stem cell transplantation, BEACOPP) planned within 2 consecutive days
* Patients up to 1 month after hematopoietic stem cell transplantation
* Clinical signs of mucositis
* Severe liver failure
* Patients undergoing intensive antimicrobial treatment
18 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Grzegorz W. Basak
Associate Professor
Principal Investigators
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Grzegorz Basak, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Hematology, Oncology and Internal Diseases, the Medical University of Warsaw
Wieslaw Wiktor-Jedrzejczak, MD, PhD
Role: STUDY_CHAIR
Department of Hematology, Oncology and Internal Diseases, the Medical University of Warsaw
Locations
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Department of Hematology, Oncology and Internal Diseaes, The Medical University of Warsaw
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Bilinski J, Grzesiowski P, Muszynski J, Wroblewska M, Madry K, Robak K, Dzieciatkowski T, Wiktor-Jedrzejczak W, Basak GW. Fecal Microbiota Transplantation Inhibits Multidrug-Resistant Gut Pathogens: Preliminary Report Performed in an Immunocompromised Host. Arch Immunol Ther Exp (Warsz). 2016 Jun;64(3):255-8. doi: 10.1007/s00005-016-0387-9. Epub 2016 Mar 9.
Other Identifiers
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02KOHAM
Identifier Type: -
Identifier Source: org_study_id
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