- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04593368
Fecal Microbiome Transplantation (FMT) in Pediatric Patients Colonized With Antibiotic-resistant Pathogens Before Hematopoietic Stem Cell Transplantation (HSCT) (FMT-HSCT)
November 30, 2020 updated by: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Prospective Non-randomized Phase II Clinical Trial of Safety and Efficacy of Fecal Microbiome Transplantation for Pediatric Patients 3-18 Years Old With Confirmed Colonization With Antibiotic-resistant Bacterias and Indication for Allogeneic Hematopoietic Stem Cell Transplantation
a clinical trial designed to prospectively assess the safety and effectiveness of fecal microbiota transplantation (FMT) prior to allogeneic hematopoietic stem-cell translation (HSCT) in patients contaminated with antibiotic-resistant pathogens (ARP)
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The investigator's question is whether FMT decontaminates ARP and as a result, decreases the risk of severe infection which leads to transplant-related morbidity and mortality after HSCT.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhanna Shekhovtsova
- Phone Number: 5553 84956647078
- Email: zhanna.shekhovtsova@fccho-moscow.ru
Study Locations
-
-
-
Moscow, Russian Federation, 117198
- Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
-
Contact:
- Zhanna Shekhovtsova
- Phone Number: 5553 84956647078
- Email: zhanna.shekhovtsova@fccho-moscow.ru
-
Moscow, Russian Federation, 119435
- Federal Research & Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency
-
Contact:
- Elena Zhgun
- Phone Number: 84992464438
- Email: al.androva@gmail.com
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Saint Petersburg, Russian Federation, 197022
- RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
-
Contact:
- Oleg GOLOSHCHAPOV
- Email: Golocht@yandex.ru
-
-
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
3 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Recipients
Inclusion Criteria:
detection by microbiology culture in any localization species of:
- Pseudomonas aeruginosa
- Clostridium difficile
- Vancomycin-resistant Enterococcus
- Streptococcus viridans
- ESBL Enterobacteriaceae, including Escherichia coli and Klebsiella pneumoniae
- Stenotrophomonas maltophilia
- Acinetobacter
- Methicillin-resistant Staphylococcus aureus
- Indications for allo-HSCT
Exclusion Criteria:
- indications for therapy with antibiotics for the next 7 days after FMT
- Nonstable condition during 1 week before FMT
- Therapy with antibiotics less than 48 hours before FMT
- Age less than 3 years
- Neutrophils count < 0,5 K/mcL at FMT day and\or predicted decrease during 2 days after Donors (healthy volunteers)
Inclusion Criteria:
- Age 3-50 years old
- Donor choosing order in the absence of contraindications:
1) HLA-match/mismatch HSCT family donor; 2) Closest family relative with whom the recipient lives; 3) Unrelated healthy volunteer from the FRCC PCM bank of frozen transplants
Exclusion Criteria:
Presens of:
- ESBL Esherihia coli
- Klebsiella pneumoniae
- Pseudomonas aeruginosa
- Clostridium difficile
- MRSA
- VRE
- Streptococcus viridans
- ESBL Enterobacteriaceae
- Stenotrophomonas maltophilia
- Acinetobacter in feces by microbiology culture assay
- Therapy with antibiotics less than 3 months before donation
- Any infection disease revealed during the screening
- Latent period of infection disease according to the questionnaire
- Gut disease
- Longitudinal treatment with drugs
- Any diet for 3 months before donation.
- Obesity (BMI ≥ 30).
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
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FMT
|
oral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness
Time Frame: 7 days after FMT
|
frequency of decolonization
|
7 days after FMT
|
frequency of SAEs
Time Frame: 1 month after FMT
|
frequency of SAEs due to FMT
|
1 month after FMT
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decolonization
Time Frame: 30 days after FMT
|
frequency of decolonization
|
30 days after FMT
|
acute gut GVHD CI
Time Frame: 100 days after HSCT
|
CI of gut GVHD
|
100 days after HSCT
|
Toxicity frequency
Time Frame: 7 days after FMT
|
frequency of severe toxicity (3-4 grade according to the CTCAE ver 5.0)
|
7 days after FMT
|
Bacteremia
Time Frame: 100 days after FMT
|
frequency of bacteremia
|
100 days after FMT
|
Translocation
Time Frame: 1 year
|
frequency of translocation of pathogens from gut
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Anticipated)
December 15, 2020
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
October 13, 2020
First Submitted That Met QC Criteria
October 13, 2020
First Posted (Actual)
October 20, 2020
Study Record Updates
Last Update Posted (Actual)
December 1, 2020
Last Update Submitted That Met QC Criteria
November 30, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- NCPHOI-2019-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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