Fecal Microbiome Transplantation (FMT) in Pediatric Patie... | NCT04593368

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2020Estimated

Primary Completion Date

Sep 2022Estimated

Completion Date

Sep 2023Estimated

First Submitted Date

Oct 13, 2020

First Submission Date that Met QC Criteria

Oct 13, 2020

First Posted Date

Oct 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2020

Last Update Posted Date

Dec 1, 2020Actual

Description Module

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.

Label	Type	Description	Intervention Names
FMT	Experimental		Other: FMT

Name	Type	Description	Arm Group Labels	Other Names
FMT	Other	oral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight	FMT

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Decolonization	frequency of decolonization	30 days after FMT
acute gut GVHD CI	CI of gut GVHD	100 days after HSCT

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Recipients

Inclusion Criteria:

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
Indications for allo-HSCT

Exclusion Criteria:

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)

Inclusion Criteria:

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

Exclusion Criteria:

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
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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided