Stool Transplantation to Reduce Antibiotic Resistance Transmission (START)

June 2, 2015 updated by: Grzegorz W. Basak, Medical University of Warsaw

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-097
        • Recruiting
        • Department of Hematology, Oncology and Internal Diseaes, The Medical University of Warsaw
        • Contact:
        • Contact:
        • Principal Investigator:
          • Grzegorz W Basak, MD, PhD
        • Sub-Investigator:
          • Jaroslaw Bilinski, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • FMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 weeks to 6 months after fecal microbiota transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Eradication of gut colonizing bacteria as proven by PCR.
Time Frame: 2 weeks to 6 months after fecal microbiota transplantation
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
from day "0" (day of FMT) to 6 months after fecal microbiota transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

May 31, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02KOHAM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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