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Stool Transplantation to Reduce Antibiotic Resistance Transmission (START)

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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
Sponsor:
Information provided by (Responsible Party):
Grzegorz W. Basak, Medical University of Warsaw

Study Description
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Brief 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 .


Condition or disease Intervention/treatment
Blood Disorders Biological: Fecal microbiota transplantation

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Eradication of gut colonizing bacteria as proven by PCR. [ Time Frame: 2 weeks to 6 months after fecal microbiota transplantation ]
  2. Incidence of infective episodes [ Time Frame: from day "0" (day of FMT) to 6 months after fecal microbiota transplantation ]

Biospecimen Retention:   Samples With DNA
Stool samples collected before and after the procedure.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461199


Contacts
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Contact: Jaroslaw Bilinski, MD +48 22 599 29 44 jaroslaw.bilinski@gmail.com
Contact: Grzegorz W Basak, MD, PhD +48 22 599 26 40 grzegorz.basak@wum.edu.pl

Locations
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Poland
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    jaroslaw.bilinski@gmail.com   
Contact: Grzegorz W Basak, MD, PhD    +48 22 599 26 40    grzegorz.basak@wum.edu.pl   
Principal Investigator: Grzegorz W Basak, MD, PhD         
Sub-Investigator: Jaroslaw Bilinski, MD         
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Grzegorz W. Basak, Associate Professor, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02461199    
Other Study ID Numbers: 02KOHAM
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Keywords provided by Grzegorz W. Basak, Medical University of Warsaw:
Fecal microbiota transplantation
Gut colonization
Multidrug-resistant bacteria
 Blood disorders
Drug Resistance, Multiple
Disease Eradication
Additional relevant MeSH terms:
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Hematologic Diseases