Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 .
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation | Biological | Transplantation of 100 ml of fecal microbiota suspension obtained from healthy unrelated donor in two consecutive days via the nasoduodenal tube |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaroslaw Bilinski, MD | Contact | +48 22 599 29 44 | jaroslaw.bilinski@gmail.com | |
| Grzegorz W Basak, MD, PhD | Contact | +48 22 599 26 40 | grzegorz.basak@wum.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Grzegorz Basak, MD, PhD | Department of Hematology, Oncology and Internal Diseases, the Medical University of Warsaw | Principal Investigator |
| Wieslaw Wiktor-Jedrzejczak, MD, PhD | Department of Hematology, Oncology and Internal Diseases, the Medical University of Warsaw |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Oncology and Internal Diseaes, The Medical University of Warsaw | Recruiting | Warsaw | 02-097 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28369341 | Derived | 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. | |
| 26960790 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Stool samples collected before and after the procedure.
|
| Study Chair |
| Derived |
| 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. |