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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04593368

Acronym

FMT-HSCT

Enrollment

Registered

2020-10-20

Start date

2020-12-15

Completion date

2023-09-30

Last updated

2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Resistant Strain

Keywords

pediatric, hematopoetic stem-cell transplantation, FMT, microbiome

Brief 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)

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.

Interventions

OTHERFMT

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 25 Years

Healthy volunteers

Yes

Inclusion criteria

Recipients 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

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) Inclusion Criteria: 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

Design outcomes

Primary

Measure	Time frame	Description
Effectiveness	7 days after FMT	frequency of decolonization
frequency of SAEs	1 month after FMT	frequency of SAEs due to FMT

Secondary

Measure	Time frame	Description
Toxicity frequency	7 days after FMT	frequency of severe toxicity (3-4 grade according to the CTCAE ver 5.0)
Decolonization	30 days after FMT	frequency of decolonization
Translocation	1 year	frequency of translocation of pathogens from gut
Bacteremia	100 days after FMT	frequency of bacteremia
acute gut GVHD CI	100 days after HSCT	CI of gut GVHD

Countries

Russia

Contacts

Primary ContactZhanna Shekhovtsova

zhanna.shekhovtsova@fccho-moscow.ru84956647078

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026