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

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: Antibiotic Resistant Strain
• Intervention / Treatment: Other: FMT

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

• Study Contact: Name: Zhanna Shekhovtsova; Phone Number: 5553 84956647078; Email: zhanna.shekhovtsova@fccho-moscow.ru

Study Locations

• Russian Federation
  • 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
  • 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

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:

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

Exclusion Criteria:

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMT	Other: 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	frequency of decolonization	7 days after FMT
frequency of SAEs	frequency of SAEs due to FMT	1 month after FMT

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Study record dates

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

• Keywords: pediatric; FMT; microbiome; hematopoetic stem-cell transplantation
• 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