Blood DisordersSTARTNCT02461199
Stool Transplantation to Reduce Antibiotic Resistance Transmission
An observational study of Blood Disorders, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Disorders
- What is being tested?
- Fecal microbiota transplantation
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2015to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Hematology, Oncology and Internal Diseaes, The Medical University of Warsaw
Warsaw, 02-097
Jaroslaw Bilinski, MD, +48 22 599 29 44, jaroslaw.bilinski@gmail.com
Grzegorz W Basak, MD, PhD, +48 22 599 26 40, grzegorz.basak@wum.edu.pl
About this study
Official title: 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 .
- Conditions
- Blood Disorders
- Being tested
- Fecal microbiota transplantation
- Keywords
- Fecal microbiota transplantation, Gut colonization, Multidrug-resistant bacteria, Blood disorders, Drug Resistance, Multiple, Disease Eradication
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationBiological
Also called FMT
Transplantation of 100 ml of fecal microbiota suspension obtained from healthy unrelated donor in two consecutive days via the nasoduodenal tube
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of gut colonizing bacteria as proven by at least two negative stool cultures.
Measured: 2 weeks to 6 months after fecal microbiota transplantation
Secondary outcomes (2)
Eradication of gut colonizing bacteria as proven by PCR.
Measured: 2 weeks to 6 months after fecal microbiota transplantation
Incidence of infective episodes
Measured: from day "0" (day of FMT) to 6 months after fecal microbiota transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood DisordersStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grzegorz W. Basak, Medical University of Warsaw
- Investigators
- Grzegorz Basak, MD, PhD, Principal investigator, Department of Hematology, Oncology and Internal Diseases, the Medical University of WarsawWieslaw Wiktor-Jedrzejczak, MD, PhD, Study chair, Department of Hematology, Oncology and Internal Diseases, the Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461199
- Sponsor's protocol ID
- 02KOHAM
- Acronym
- START
- Status last verified
- Jun 2015
- First submitted
- 28 May 2015
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28369341Bilinski 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.
PubMed 26960790
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Fecal Microbiota Transplantation Used to Eradicate Gut-colonizing Multidrug-resistant Bacteria in Patients With Blood Disorders
- ClinicalTrials.gov ID
- NCT02461199
- Acronym / sponsor ID
- START / 02KOHAM
- Conditions
- Blood Disorders
- Keywords
- Fecal microbiota transplantation, Gut colonization, Multidrug-resistant bacteria, Blood disorders, Drug Resistance, Multiple, Disease Eradication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation | – | Biological: Fecal microbiota transplantationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantationAlso: FMTTransplantation of 100 ml of fecal microbiota suspension obtained from healthy unrelated donor in two consecutive days via the nasoduodenal tube | Biological | Fecal microbiota transplantation |
Primary outcome
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 secondary outcomes
Eradication of gut colonizing bacteria as proven by PCR.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Derived from this study: PubMed 28369341Bilinski 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.
- Derived from this study: PubMed 26960790Bilinski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grzegorz Basak, MD, PhD principal investigator
Department of Hematology, Oncology and Internal Diseases, the Medical University of Warsaw
Wieslaw Wiktor-Jedrzejczak, MD, PhD study chair
Department of Hematology, Oncology and Internal Diseases, the Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Disorders, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaroslaw Bilinski, MD (+48 22 599 29 44, jaroslaw.bilinski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02461199, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.