Modification of the Human Colon and Oral Microbiome by Allogenic HSCT
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedStudy Start
First participant enrolled
May 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedApril 7, 2020
April 1, 2020
1.8 years
April 29, 2019
April 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (8)
Proportion of patients with microbial domination after HSCT
7 days after HSCT
Proportion of patients with microbial domination after HSCT
60 days after HSCT
Shannon-index dynamics
7 days before HSCT
Shannon-index dynamics
7 days after HSCT
Shannon-index dynamics
60 days after HSCT
- +3 more secondary outcomes
Study Arms (2)
Donors
HLA-matched or haploidentical nursing relative donors
Patients
recipients of allogeneic HSCT
Eligibility Criteria
pediatric recipients and their donors receiving treatment in the Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology, and Immunology
You may qualify if:
- indications to alloHSCT
- nursing healthy donors 3-55 y.o.
You may not qualify if:
- unable to give samples for the test
- graft rejection
- previous HSCT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Moscow, 117997, Russia
Biospecimen
colon and oral swab
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Maschan, PhD
National Research Center for Pediatric Hematology , Moscow, Russian Federation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2019
First Posted
May 8, 2019
Study Start
May 14, 2019
Primary Completion
March 1, 2021
Study Completion
March 1, 2023
Last Updated
April 7, 2020
Record last verified: 2020-04