Modification of the Human Colon and Oral Microbiome by Allogenic HSCT

NCT ID: NCT03942159

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-14

Study Completion Date

2023-03-31

Brief Summary

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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

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Conditions

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Human Microbiome HSCT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Donors

HLA-matched or haploidentical nursing relative donors

No interventions assigned to this group

Patients

recipients of allogeneic HSCT

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal Research Institute of Pediatric Hematology, Oncology and Immunology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Maschan, PhD

Role: PRINCIPAL_INVESTIGATOR

National Research Center for Pediatric Hematology , Moscow, Russian Federation

Locations

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Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Zhanna Shekhovtsova

Role: CONTACT

84956647078 ext. 7538

Facility Contacts

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Zhanna Shekhovtsova, MD

Role: primary

4956647078 ext. 7538

Other Identifiers

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NCHPOI-2019-01

Identifier Type: -

Identifier Source: org_study_id

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