Clinical trial NCT02461199: Stool Transplantation to Reduce Antibiotic Resistance Transmission
Official title: Prospective Observational Study of Fecal Microbiota Transplantation Used to Eradicate Gut-colonizing Multidrug-resistant Bacteria in Patients With Blood Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Disorders
Keywords: Fecal microbiota transplantation
Gut colonization
Multidrug-resistant bacteria
Blood disorders
Drug Resistance, Multiple
Disease Eradication
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with blood disorders treated in the Department of Hematology, Oncology and Internal Diseases, with positive gut colonization status with MDR bacteria, who consent for fecal microbiota transplantation.

Brief summary: During this prospective observational study, the investigators collect the information about the outcomes of fecal microbiota transplantation in patients with blood disorders, performed to eradicate gut colonization with multidrug-resistant (MDR) bacteria.

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 .


Eligibility criteria: Inclusion Criteria:

* Age \>18 y
* 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:

* 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
* 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

Primary outcomes:
measure: Eradication of gut colonizing bacteria as proven by at least two negative stool cultures.
timeFrame: 2 weeks to 6 months after fecal microbiota transplantation
Secondary outcomes:
measure: Eradication of gut colonizing bacteria as proven by PCR.
timeFrame: 2 weeks to 6 months after fecal microbiota transplantation
measure: Incidence of infective episodes
timeFrame: from day "0" (day of FMT) to 6 months after fecal microbiota transplantation
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Hematology, Oncology and Internal Diseaes, The Medical University of Warsaw
Study officials:
affiliation: Department of Hematology, Oncology and Internal Diseases, the Medical University of Warsaw
name: Grzegorz Basak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Hematology, Oncology and Internal Diseases, the Medical University of Warsaw
name: Wieslaw Wiktor-Jedrzejczak, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.