Antibiotic Resistant StrainPhase 2FMT-HSCTNCT04593368
Fecal Microbiome Transplantation (FMT) in Pediatric Patients Colonized With Antibiotic-resistant Pathogens Before Hematopoietic Stem Cell Transplantation (HSCT)
A Phase 2 study testing FMT in people with Antibiotic Resistant Strain, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 3 sites in Russia.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 3 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Resistant Strain
- What is being tested?
- FMT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesRussia
- Study dates
- 15 Dec 2020to Sep 2023
- Phase
- Phase 2
- 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 3 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- Stenotrophomonas maltophilia
- Acinetobacter
- Methicillin-resistant Staphylococcus aureus
- Indications for allo-HSCT
- 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
Who cannot join
- 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)
- Presens of:
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- 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).
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
Moscow, 117198
Zhanna Shekhovtsova, 84956647078 ext. 5553, zhanna.shekhovtsova@fccho-moscow.ru
Federal Research & Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency
Moscow, 119435
Elena Zhgun, 84992464438, al.androva@gmail.com
RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
Saint Petersburg, 197022
Oleg GOLOSHCHAPOV, Golocht@yandex.ru
About this study
Official title: 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)
Read the 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.
- Conditions
- Antibiotic Resistant Strain
- Being tested
- FMT
- Keywords
- pediatric, hematopoetic stem-cell transplantation, FMT, microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMTOther
oral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight
| Study group | Role | What they receive |
|---|---|---|
| FMT | Experimental | Not described Receives: Other: FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
frequency of decolonization
Measured: 7 days after FMT
frequency of SAEs
frequency of SAEs due to FMT
Measured: 1 month after FMT
Secondary outcomes (5)
Decolonization
frequency of decolonization
Measured: 30 days after FMT
acute gut GVHD CI
CI of gut GVHD
Measured: 100 days after HSCT
Toxicity frequency
frequency of severe toxicity (3-4 grade according to the CTCAE ver 5.0)
Measured: 7 days after FMT
Bacteremia
frequency of bacteremia
Measured: 100 days after FMT
Translocation
frequency of translocation of pathogens from gut
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start15 Dec 2020 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic Resistant StrainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593368
- Sponsor's protocol ID
- NCPHOI-2019-04
- Acronym
- FMT-HSCT
- Status last verified
- Nov 2020
- First submitted
- 13 Oct 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04593368
- Acronym / sponsor ID
- FMT-HSCT / NCPHOI-2019-04
- Conditions
- Antibiotic Resistant Strain
- Keywords
- pediatric, hematopoetic stem-cell transplantation, FMT, microbiome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 20 Oct 2020 (actual)
- 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.
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)
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT | Experimental | Other: FMT |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- detection by microbiology culture in any localization species of:
- Indications for allo-HSCT
- 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
Key exclusion criteria (23 listed)
- 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)
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 |
|---|---|---|
| FMToral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight | Other | FMT |
Primary outcome
Effectiveness
Time frame: 7 days after FMT
frequency of decolonization
frequency of SAEs
Time frame: 1 month after FMT
frequency of SAEs due to FMT
5 secondary outcomes
Decolonization
Time frame: 30 days after FMT
acute gut GVHD CI
Time frame: 100 days after HSCT
Toxicity frequency
Time frame: 7 days after FMT
Bacteremia
Time frame: 100 days after FMT
Translocation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FMT in people with Antibiotic Resistant Strain, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 3 sites in Russia.
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 13 inclusion and 23 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 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhanna Shekhovtsova (84956647078 ext. 5553, zhanna.shekhovtsova@fccho-moscow.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: 7 days after FMT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2020.