Stool Transplantation to Reduce Antibiotic Resistance Transmission

Blood Disorders Clinical Trial

— START  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02461199
• Other study ID #: 02KOHAM
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2015
• Last updated: June 2, 2015
• Start date: February 2015
• Est. completion date: September 2017

Study information

• Verified date: June 2015
• Source: Medical University of Warsaw
• Contact: Jaroslaw Bilinski, MD
• Phone: +48 22 599 29 44
• Email: jaroslaw.bilinski[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ethics CommitteePoland: Ministry of Health
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Disorders
• Hematologic Diseases

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Hematology, Oncology and Internal Diseaes, The Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication of gut colonizing bacteria as proven by at least two negative stool cultures.		2 weeks to 6 months after fecal microbiota transplantation	No
Secondary	Eradication of gut colonizing bacteria as proven by PCR.		2 weeks to 6 months after fecal microbiota transplantation	No
Secondary	Incidence of infective episodes		from day "0" (day of FMT) to 6 months after fecal microbiota transplantation	Yes