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Fecal Microbiome Transplantation (FMT) in Pediatric Patients Colonized With Antibiotic-resistant Pathogens Before Hematopoietic Stem Cell Transplantation (HSCT)

NCT ID: NCT04593368

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2023-09-30

Brief Summary

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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

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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

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Antibiotic Resistant Strain

Keywords

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pediatric hematopoetic stem-cell transplantation FMT microbiome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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FMT

Group Type EXPERIMENTAL

FMT

Intervention Type OTHER

oral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight

Interventions

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FMT

oral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Indications for allo-HSCT


1. Age 3-50 years old
2. 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

1. indications for therapy with antibiotics for the next 7 days after FMT
2. Nonstable condition during 1 week before FMT
3. Therapy with antibiotics less than 48 hours before FMT
4. Age less than 3 years
5. Neutrophils count \< 0,5 K/mcL at FMT day and\\or predicted decrease during 2 days after Donors (healthy volunteers)


1. 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
2. Therapy with antibiotics less than 3 months before donation
3. Any infection disease revealed during the screening
4. Latent period of infection disease according to the questionnaire
5. Gut disease
6. Longitudinal treatment with drugs
7. Any diet for 3 months before donation.
8. Obesity (BMI ≥ 30).
Minimum Eligible Age

3 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal Research Institute of Pediatric Hematology, Oncology and Immunology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology

Moscow, , Russia

Site Status

Federal Research & Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency

Moscow, , Russia

Site Status

RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University

Saint Petersburg, , Russia

Site Status

Countries

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Russia

Central Contacts

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Zhanna Shekhovtsova

Role: CONTACT

Phone: 84956647078

Email: [email protected]

Facility Contacts

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Zhanna Shekhovtsova

Role: primary

Elena Zhgun

Role: primary

Oleg GOLOSHCHAPOV

Role: primary

Other Identifiers

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NCPHOI-2019-04

Identifier Type: -

Identifier Source: org_study_id