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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donors | HLA-matched or haploidentical nursing relative donors | ||
| Patients | recipients of allogeneic HSCT |
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| Measure | Description | Time Frame |
|---|---|---|
| beta-index dynamics | biodiversity (beta-index) dynamics between time points before and after HSCT | 7 days before HSCT |
| beta-index dynamics | biodiversity (beta-index) dynamics between time points before and after HSCT | 7 days after HSCT |
| beta-index dynamics | biodiversity (beta-index) dynamics between time points before and after HSCT | 60 days after HSCT |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with microbial domination after HSCT | evaluation of the dynamics of the microbial domination between time points before and after HSCT | 7 days after HSCT |
| Proportion of patients with microbial domination after HSCT |
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Inclusion Criteria:
Exclusion Criteria:
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pediatric recipients and their donors receiving treatment in the Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology, and Immunology
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhanna Shekhovtsova | Contact | 84956647078 | 7538 | zhanna.shekhovtsova@fccho-moscow.ru |
| Name | Affiliation | Role |
|---|---|---|
| Michael Maschan, PhD | National Research Center for Pediatric Hematology , Moscow, Russian Federation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology | Recruiting | Moscow | 117997 | Russia |
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colon and oral swab
evaluation of the dynamics of the microbial domination between time points before and after HSCT
| 60 days after HSCT |
| Shannon-index dynamics | 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 | 7 days before HSCT |
| Shannon-index dynamics | 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 | 7 days after HSCT |
| Shannon-index dynamics | 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 | 60 days after HSCT |
| ROC (receiver operating characteristic)-curve of NGS (new-generation sequence) | sensitivity of NGS as a method of biodiversity evaluation | 7 days before HSCT |
| ROC (receiver operating characteristic)-curve of NGS (new-generation sequence) | sensitivity of NGS as a method of biodiversity evaluation | 7 days after HSCT |
| ROC (receiver operating characteristic)-curve of NGS (new-generation sequence) | sensitivity of NGS as a method of biodiversity evaluation | 60 days after HSCT |