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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 June 2015 |
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Main ID: |
NCT02461199 |
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Date of registration:
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28/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Stool Transplantation to Reduce Antibiotic Resistance Transmission
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Scientific title:
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Prospective Observational Study of Fecal Microbiota Transplantation Used to Eradicate Gut-colonizing Multidrug-resistant Bacteria in Patients With Blood Disorders |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02461199 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Poland
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Contacts
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Name:
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Jaroslaw Bilinski, MD |
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Address:
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Telephone:
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+48 22 599 29 44 |
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Email:
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jaroslaw.bilinski@gmail.com |
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Affiliation:
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Name:
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Wieslaw Wiktor-Jedrzejczak, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Hematology, Oncology and Internal Diseases, the Medical University of Warsaw |
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Name:
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Jaroslaw Bilinski, MD |
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Address:
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Telephone:
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+48 22 599 29 44 |
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Email:
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jaroslaw.bilinski@gmail.com |
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Affiliation:
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Name:
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Grzegorz Basak, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Hematology, Oncology and Internal Diseases, the Medical University of Warsaw |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Blood Disorders
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Intervention(s)
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Biological: Fecal microbiota transplantation
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Incidence of infective episodes
[Time Frame: from day "0" (day of FMT) to 6 months after fecal microbiota transplantation]
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Eradication of gut colonizing bacteria as proven by PCR.
[Time Frame: 2 weeks to 6 months after fecal microbiota transplantation]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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