Alterations in Intestinal Microbiota, Metabolites, and Immune Cells in Allo-HSCT
NCT ID: NCT06143501
Last Updated: 2023-11-22
Study Results
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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RECRUITING
250 participants
OBSERVATIONAL
2020-09-01
2024-12-31
Brief Summary
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Detailed Description
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This research initiative aims to collect peripheral blood, fecal, and urine samples from 200 patients before and after transplantation as well as 50 healthy volunteers. Comprehensive analyses, including metagenomics, 16S rRNA sequencing, transcriptomics, metabolomics, single-cell sequencing, as well as assessments of immune cell function and inflammatory cytokines, will be conducted. Additionally, longitudinal follow-up observations will be performed to monitor post-transplant complications, relapse and immune reconstitution.
By investigating the dynamics of gut microbiota, metabolites, and cellular metabolism and analyzing their correlation with changes in immune responses, this study seeks to elucidate the roles of intestinal microbiota, metabolites, and immune cell metabolism in the context of allo-HSCT. The findings are anticipated to provide insights into the correlation between these factors and outcomes of allo-HSCT patients, contributing valuable evidence for the diagnosis and prognosis assessment of complications following transplantation.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Allo-HSCT Recipients
Blood Sample
6 ml blood (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
Stool Sample
pea-sized amount (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
Urine Sample
8 ml (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
Healthy Volunteers
Blood Sample
6 ml blood (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
Stool Sample
pea-sized amount (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
Urine Sample
8 ml (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
Interventions
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Blood Sample
6 ml blood (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
Stool Sample
pea-sized amount (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
Urine Sample
8 ml (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Diagnosis of autoimmune diseases, metabolic disorders, and chronic gastrointestinal diseases.
* Pre-transplant diseases not in complete remission.
* Post-transplant hematopoietic engraftment failure or pre-engraftment mortality.
ALL
Yes
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Principal Investigators
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Yang Xu, M.D
Role: STUDY_CHAIR
The First Affiliated Hospital of Soochow University
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pre-Post Allo-HSCT Monitoring
Identifier Type: -
Identifier Source: org_study_id