Stool Transplantation to Reduce Antibiotic Resistance Transmission

Study Overview
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Brief Summary
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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 .

Official Title
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Prospective Observational Study of Fecal Microbiota Transplantation Used to Eradicate Gut-colonizing Multidrug-resistant Bacteria in Patients With Blood Disorders

Conditions
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Blood Disorders

Intervention / Treatment
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* Biological: Fecal microbiota transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fecal microbiota transplantation<br>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. | Biological: Fecal microbiota transplantation<br>* Transplantation of 100 ml of fecal microbiota suspension obtained from healthy unrelated donor in two consecutive days via the nasoduodenal tube<br>* Other names: FMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication of gut colonizing bacteria as proven by at least two negative stool cultures. |  | 2 weeks to 6 months after fecal microbiota transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication of gut colonizing bacteria as proven by PCR. |  | 2 weeks to 6 months after fecal microbiota transplantation | 
| Incidence of infective episodes |  | from day 0 (day of FMT) to 6 months after fecal microbiota transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal microbiota transplantation, Gut colonization, Multidrug-resistant bacteria, Blood disorders, Drug Resistance, Multiple, Disease Eradication