Modification of the Human Colon and Oral Microbiome by Allogenic HSCT

Study Overview
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Brief Summary
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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.

Official Title
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Modification of the Human Colon and Oral Microbiome by Allogeneic HSCT in Recipients and Correlation With the Microbiome of the Donor

Conditions
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Human Microbiome, HSCT

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indications to alloHSCT nursing healthy donors 3-55 y.o. Exclusion Criteria: unable to give samples for the test graft rejection previous HSCT

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Donors<br>HLA-matched or haploidentical nursing relative donors | |
| Patients<br>recipients of allogeneic HSCT | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, stem cell transplantation