UnknownPhase 2

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

Russia15 participantsStarted 2020-12-15

Plain-language 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)

Who can participate

Age range

3 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. detection by microbiology culture in any localization species of:
. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effectiveness

Timeframe: 7 days after FMT

frequency of SAEs

Timeframe: 1 month after FMT

Trial details

NCT IDNCT04593368

SponsorFederal Research Institute of Pediatric Hematology, Oncology and Immunology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09

Contact for this trial

Zhanna Shekhovtsova

84956647078 zhanna.shekhovtsova@fccho-moscow.ru

View on ClinicalTrials.gov More Antibiotic Resistant Strain trials