Modification of the Human Colon and Oral Microbiome by Allogenic HSCT

April 6, 2020 updated by: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 117997
        • Recruiting
        • Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
        • Sub-Investigator:
          • Zhanna Shekhovtsova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pediatric recipients and their donors receiving treatment in the Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology, and Immunology

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Donors
HLA-matched or haploidentical nursing relative donors
Patients
recipients of allogeneic HSCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
beta-index dynamics
Time Frame: 7 days before HSCT
biodiversity (beta-index) dynamics between time points before and after HSCT
7 days before HSCT
beta-index dynamics
Time Frame: 7 days after HSCT
biodiversity (beta-index) dynamics between time points before and after HSCT
7 days after HSCT
beta-index dynamics
Time Frame: 60 days after HSCT
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
Time Frame: 7 days 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
Time Frame: 60 days after HSCT
evaluation of the dynamics of the microbial domination between time points before and after HSCT
60 days after HSCT
Shannon-index dynamics
Time Frame: 7 days before 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
7 days before HSCT
Shannon-index dynamics
Time Frame: 7 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
7 days after HSCT
Shannon-index dynamics
Time Frame: 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
60 days after HSCT
ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)
Time Frame: 7 days before HSCT
sensitivity of NGS as a method of biodiversity evaluation
7 days before HSCT
ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)
Time Frame: 7 days after HSCT
sensitivity of NGS as a method of biodiversity evaluation
7 days after HSCT
ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)
Time Frame: 60 days after HSCT
sensitivity of NGS as a method of biodiversity evaluation
60 days after HSCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Investigators

  • Principal Investigator: Michael Maschan, PhD, National Research Center for Pediatric Hematology , Moscow, Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2019

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

May 6, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NCHPOI-2019-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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