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出境医 / 临床实验 / Modification of the Human Colon and Oral Microbiome by Allogenic HSCT

Modification of the Human Colon and Oral Microbiome by Allogenic HSCT

Study Description
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.

Condition or disease
Human Microbiome HSCT

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Modification of the Human Colon and Oral Microbiome by Allogeneic HSCT in Recipients and Correlation With the Microbiome of the Donor
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2023
Arms and Interventions
Group/Cohort
Donors
HLA-matched or haploidentical nursing relative donors
Patients
recipients of allogeneic HSCT
Outcome Measures
Primary Outcome Measures :
  1. beta-index dynamics [ Time Frame: 7 days before HSCT ]
    biodiversity (beta-index) dynamics between time points before and after HSCT

  2. beta-index dynamics [ Time Frame: 7 days after HSCT ]
    biodiversity (beta-index) dynamics between time points before and after HSCT

  3. beta-index dynamics [ Time Frame: 60 days after HSCT ]
    biodiversity (beta-index) dynamics between time points before and after HSCT


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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. 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

  8. 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


Biospecimen Retention:   Samples With DNA
colon and oral swab

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations

Contacts
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Contact: Zhanna Shekhovtsova 84956647078 ext 7538 zhanna.shekhovtsova@fccho-moscow.ru

Locations
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Russian Federation
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology Recruiting
Moscow, Russian Federation, 117997
Contact: Zhanna Shekhovtsova, MD    4956647078 ext 7538    zhanna.shekhovtsova@fccho-moscow.ru   
Principal Investigator: Michael Maschan, PhD         
Sub-Investigator: Zhanna Shekhovtsova         
Sponsors and Collaborators
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Investigators
Layout table for investigator information
Principal Investigator: Michael Maschan, PhD National Research Center for Pediatric Hematology , Moscow, Russian Federation
Tracking Information
First Submitted Date April 29, 2019
First Posted Date May 8, 2019
Last Update Posted Date April 7, 2020
Actual Study Start Date May 14, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2019)
  • beta-index dynamics [ Time Frame: 7 days before HSCT ]
    biodiversity (beta-index) dynamics between time points before and after HSCT
  • beta-index dynamics [ Time Frame: 7 days after HSCT ]
    biodiversity (beta-index) dynamics between time points before and after HSCT
  • beta-index dynamics [ Time Frame: 60 days after HSCT ]
    biodiversity (beta-index) dynamics between time points before and after HSCT
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 6, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Modification of the Human Colon and Oral Microbiome by Allogenic HSCT
Official Title Modification of the Human Colon and Oral Microbiome by Allogeneic HSCT in Recipients and Correlation With the Microbiome of the Donor
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
colon and oral swab
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
Condition
  • Human Microbiome
  • HSCT
Intervention Not Provided
Study Groups/Cohorts
  • Donors
    HLA-matched or haploidentical nursing relative donors
  • Patients
    recipients of allogeneic HSCT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 6, 2019) 		15
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2023
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Zhanna Shekhovtsova 84956647078 ext 7538 zhanna.shekhovtsova@fccho-moscow.ru
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT03942159
Other Study ID Numbers NCHPOI-2019-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Study Sponsor Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Collaborators Not Provided
Investigators
Principal Investigator: Michael Maschan, PhD National Research Center for Pediatric Hematology , Moscow, Russian Federation
PRS Account Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Verification Date April 2020

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