Modification of the Human Colon and Oral Microbiome by Allogenic HSCT

• Conditions: HSCT; Human Microbiome

• Registration Number: NCT03942159
• Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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

Study Timeline

• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-08
• Study Start: 2019-05-14
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-07
• Primary Completion: 2021-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

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
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
ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)	60 days after HSCT	sensitivity of NGS as a method of biodiversity evaluation

Trial Locations

Locations (1)

Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology; 🇷🇺 Moscow, Russian Federation