NCT02461199

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

2 years

First QC Date

May 28, 2015

Last Update Submit

June 2, 2015

Conditions

Blood Disorders

Keywords

Fecal microbiota transplantationGut colonizationMultidrug-resistant bacteriaBlood disordersDrug Resistance, MultipleDisease Eradication

Outcome Measures

Primary Outcomes (1)

  • Eradication of gut colonizing bacteria as proven by at least two negative stool cultures.

    2 weeks to 6 months after fecal microbiota transplantation

Secondary Outcomes (2)

  • 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

Study Arms (1)

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

Interventions

Fecal microbiota transplantationBIOLOGICAL

Transplantation of 100 ml of fecal microbiota suspension obtained from healthy unrelated donor in two consecutive days via the nasoduodenal tube

Also known as: FMT
Fecal microbiota transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology, Oncology and Internal Diseaes, The Medical University of Warsaw

Warsaw, 02-097, Poland

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28369341DERIVED

  • 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.

    PMID: 26960790DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples collected before and after the procedure.

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • 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

    STUDY CHAIR

Central Study Contacts

Jaroslaw Bilinski, MD

CONTACT

+48 22 599 29 44jaroslaw.bilinski@gmail.com

Grzegorz W Basak, MD, PhD

CONTACT

+48 22 599 26 40grzegorz.basak@wum.edu.pl

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 3, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Study Completion

September 1, 2017

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

PL(1)