Modification of the Human Colon and Oral Microbiome by Allogenic HSCT

Human Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03942159
• Other study ID #: NCHPOI-2019-01
• Status: Recruiting
• Start date: May 14, 2019
• Est. completion date: March 2023

Study information

• Verified date: April 2020
• Source: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Contact: Zhanna Shekhovtsova
• Phone: 84956647078
• Email: zhanna.shekhovtsova[@]fccho-moscow.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2023
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• HSCT
• Human Microbiome

Locations

Country	Name	City	State
Russian Federation	Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	beta-index dynamics	biodiversity (beta-index) dynamics between time points before and after HSCT	7 days before HSCT
Primary	beta-index dynamics	biodiversity (beta-index) dynamics between time points before and after HSCT	7 days after HSCT
Primary	beta-index dynamics	biodiversity (beta-index) dynamics between time points before and after HSCT	60 days after HSCT
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)	sensitivity of NGS as a method of biodiversity evaluation	7 days before HSCT
Secondary	ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)	sensitivity of NGS as a method of biodiversity evaluation	7 days after HSCT
Secondary	ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)	sensitivity of NGS as a method of biodiversity evaluation	60 days after HSCT