Stool Transplantation to Reduce Antibiotic Resistance Transmission (START)

Medical University of Warsaw

Status: Unknown

Conditions: Blood Disorders

Treatments: Biological: Fecal microbiota transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT02461199

02KOHAM

Details and patient eligibility

About

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 .

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Fecal microbiota transplantation

Description:

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.

Treatment:

Biological: Fecal microbiota transplantation