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

Antibiotic Resistant Strain Clinical Trial

— FMT-HSCT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04593368
• Other study ID #: NCPHOI-2019-04
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 15, 2020
• Est. completion date: September 2023

Study information

• Verified date: November 2020
• Source: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Contact: Zhanna Shekhovtsova
• Phone: 84956647078
• Email: zhanna.shekhovtsova[@]fccho-moscow.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: September 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 25 Years

Eligibility

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).

Related Conditions & MeSH terms

• Antibiotic Resistant Strain
• Sprains and Strains

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology	Moscow
Russian Federation	Federal Research & Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency	Moscow
Russian Federation	RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Country where clinical trial is conducted

Russian Federation, 

Outcome

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