Modification of the Human Colon and Oral Microbiome by Allogenic HSCT
- Conditions
- HSCTHuman Microbiome
- Registration Number
- NCT03942159
- Brief Summary
Allogenic HSCT brings significant changes in biodiversity and composition of the gut microbiome through antibiotic usage, the mucosal damage due to the chemo- and radiotherapy toxicity; compromised oral nutritional intake and graft-versus-host disease with gut damage as the complication. Aim of the study is to investigate the composition of the microbiota in both recipient and nursing relative donor, reveal changes in biodiversity after HSCT via 3-time points V3V4 16S rRNA and NGS sequencing of the colon and oral swabs, 3-indoxyl-sulfate measurement in the urine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
- indications to alloHSCT
- nursing healthy donors 3-55 y.o.
- unable to give samples for the test
- graft rejection
- previous HSCT
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method beta-index dynamics 60 days after HSCT biodiversity (beta-index) dynamics between time points before and after HSCT
- Secondary Outcome Measures
Name Time Method ROC (receiver operating characteristic)-curve of NGS (new-generation sequence) 60 days after HSCT sensitivity of NGS as a method of biodiversity evaluation
Proportion of patients with microbial domination after HSCT 60 days after HSCT evaluation of the dynamics of the microbial domination between time points before and after HSCT
Shannon-index dynamics 60 days after HSCT biodiversity (Shannon-index - an information statistic index, which means it assumes all species are represented in a sample and that they are randomly sampled) dynamics between time points before and after HSCT
Trial Locations
- Locations (1)
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
🇷🇺Moscow, Russian Federation