Stool Transplantation to Reduce Antibiotic Resistance Transmission (START)
|ClinicalTrials.gov Identifier: NCT02461199|
Recruitment Status : Unknown
Verified June 2015 by Grzegorz W. Basak, Medical University of Warsaw.
Recruitment status was: Recruiting
First Posted : June 3, 2015
Last Update Posted : June 4, 2015
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 .
|Condition or disease||Intervention/treatment|
|Blood Disorders||Biological: Fecal microbiota transplantation|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Prospective Observational Study of Fecal Microbiota Transplantation Used to Eradicate Gut-colonizing Multidrug-resistant Bacteria in Patients With Blood Disorders|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||September 2017|
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.
Biological: 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 Name: FMT
- Eradication of gut colonizing bacteria as proven by at least two negative stool cultures. [ Time Frame: 2 weeks to 6 months after fecal microbiota transplantation ]
- Eradication of gut colonizing bacteria as proven by PCR. [ Time Frame: 2 weeks to 6 months after fecal microbiota transplantation ]
- Incidence of infective episodes [ Time Frame: from day "0" (day of FMT) to 6 months after fecal microbiota transplantation ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461199
|Contact: Jaroslaw Bilinski, MD||+48 22 599 29 firstname.lastname@example.org|
|Contact: Grzegorz W Basak, MD, PhD||+48 22 599 26 email@example.com|
|Department of Hematology, Oncology and Internal Diseaes, The Medical University of Warsaw||Recruiting|
|Warsaw, Poland, 02-097|
|Contact: Jaroslaw Bilinski, MD +48 22 599 29 44 firstname.lastname@example.org|
|Contact: Grzegorz W Basak, MD, PhD +48 22 599 26 40 email@example.com|
|Principal Investigator: Grzegorz W Basak, MD, PhD|
|Sub-Investigator: Jaroslaw Bilinski, MD|
|Principal Investigator:||Grzegorz Basak, MD, PhD||Department of Hematology, Oncology and Internal Diseases, the Medical University of Warsaw|
|Study Chair:||Wieslaw Wiktor-Jedrzejczak, MD, PhD||Department of Hematology, Oncology and Internal Diseases, the Medical University of Warsaw|