Graft Vs Host DiseaseNCT06143501
Alterations in Intestinal Microbiota, Metabolites, and Immune Cells in Allo-HSCT
An observational study of Graft Vs Host Disease, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This research project delves into the critical role of gut immunity in the occurrence and progression of acute graft-versus-host disease (aGVHD) post allogeneic hematopoietic stem cell transplantation (allo-HSCT). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Graft Vs Host Disease
- What is being tested?
- Blood Sample, Stool Sample and Urine Sample
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Hematological patients will receive allo-HSCT in short time.
Who may be able to join
- Patients with hematologic disorders undergoing allo-HSCT.
Who cannot join
- Patients with confirmed pathogenic intestinal infections and severe systemic infections at the time of sampling.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Yang Xu, M.D, +86 521 67780322, yangxu@suda.edu.cn
About this study
Official title: Alterations in Intestinal Microbiota, Metabolites, and Immune Cells Pre- and Post-Transplantation of Allogeneic Hematopoietic Stem Cells
This research project delves into the critical role of gut immunity in the occurrence and progression of acute graft-versus-host disease (aGVHD) post allogeneic hematopoietic stem cell transplantation (allo-HSCT). Addressing the current gaps in understanding the involvement of intestinal microbiota, metabolites, and cellular metabolism in clinical aGVHD, the study involves comprehensive analyses on 200 allo-HSCT patients and 50 healthy volunteers. By scrutinizing changes in gut microbiota, metabolites, and immune cell metabolism, the research aims to shed light on their roles in allo-HSCT and their correlation with post-transplant complications. The findings are poised to offer crucial insights for diagnosing and prognosticating complications following transplantation.
Read the detailed description
The intestinal immune system plays a pivotal role in the onset, progression, and evolution of acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the precise contributions and mechanisms underlying the involvement of intestinal microbiota, metabolites, and cellular metabolism in immune regulation during clinical aGVHD remain unclear.
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
- Graft Vs Host Disease
- Being tested
- Blood Sample, Stool Sample, Urine Sample
- Keywords
- Allo-HSCT, Intestinal Microbiota, Metabolites, Immunity
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleDiagnostic test
6 ml blood (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
Stool SampleDiagnostic test
pea-sized amount (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
Urine SampleDiagnostic test
8 ml (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
| Study group | Role | What they receive |
|---|---|---|
| Allo-HSCT Recipients | Not described Receives: Diagnostic Test: Blood Sample; Diagnostic Test: Stool Sample; Diagnostic Test: Urine Sample | |
| Healthy Volunteers | Not described Receives: Diagnostic Test: Blood Sample; Diagnostic Test: Stool Sample; Diagnostic Test: Urine Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Complications
Recording and monitoring the occurrence of complications such as infection, GVHD, etc., documenting their onset time, type, severity, and management.
Measured: 2 years
Relapse
Documenting and monitoring the occurrence of relapse in study subjects, including recording the time of onset, severity, and management.
Measured: 2 years
Overall Survival
OS will be assessed from the first day of stem cells infused to death or last follow-up.
Measured: 2 years
Secondary outcomes (1)
Immune Function
Incidence of neutrophil recovery; Incidence of lymphocyte and monocyte subset recovery
Measured: Measured 3 months after stem cells infused
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Sep 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Xu, M.D, Study chair, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143501
- Sponsor's protocol ID
- Pre-Post Allo-HSCT Monitoring
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in Intestinal Microbiota, Metabolites, and Immune Cells Pre- and Post-Transplantation of Allogeneic Hematopoietic Stem Cells
- ClinicalTrials.gov ID
- NCT06143501
- Acronym / sponsor ID
- Pre-Post Allo-HSCT Monitoring
- Conditions
- Graft Vs Host Disease
- Keywords
- Allo-HSCT, Intestinal Microbiota, Metabolites, Immunity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research project delves into the critical role of gut immunity in the occurrence and progression of acute graft-versus-host disease (aGVHD) post allogeneic hematopoietic stem cell transplantation (allo-HSCT). Addressing the current gaps in understanding the involvement of intestinal microbiota, metabolites, and cellular metabolism in clinical aGVHD, the study involves comprehensive analyses on 200 allo-HSCT patients and 50 healthy volunteers. By scrutinizing changes in gut microbiota, metabolites, and immune cell metabolism, the research aims to shed light on their roles in allo-HSCT and their correlation with post-transplant complications. The findings are poised to offer crucial insights for diagnosing and prognosticating complications following transplantation.
Detailed description
The intestinal immune system plays a pivotal role in the onset, progression, and evolution of acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the precise contributions and mechanisms underlying the involvement of intestinal microbiota, metabolites, and cellular metabolism in immune regulation during clinical aGVHD remain unclear.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allo-HSCT Recipients | – | Diagnostic Test: Blood Sample, Diagnostic Test: Stool Sample, Diagnostic Test: Urine Sample |
| Healthy Volunteers | – | Diagnostic Test: Blood Sample, Diagnostic Test: Stool Sample, Diagnostic Test: Urine Sample |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hematological patients will receive allo-HSCT in short time.
Key inclusion criteria (1 listed)
- Patients with hematologic disorders undergoing allo-HSCT.
Key exclusion criteria (4 listed)
- Patients with confirmed pathogenic intestinal infections and severe systemic infections at the time of sampling.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample6 ml blood (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation) | Diagnostic test | Allo-HSCT Recipients, Healthy Volunteers |
| Stool Samplepea-sized amount (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation) | Diagnostic test | Allo-HSCT Recipients, Healthy Volunteers |
| Urine Sample8 ml (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation) | Diagnostic test | Allo-HSCT Recipients, Healthy Volunteers |
Primary outcome
Incidence of Complications
Time frame: 2 years
Recording and monitoring the occurrence of complications such as infection, GVHD, etc., documenting their onset time, type, severity, and management.
Relapse
Time frame: 2 years
Documenting and monitoring the occurrence of relapse in study subjects, including recording the time of onset, severity, and management.
Overall Survival
Time frame: 2 years
OS will be assessed from the first day of stem cells infused to death or last follow-up.
1 secondary outcome
Immune Function
Time frame: Measured 3 months after stem cells infused
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Graft vs Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Xu, M.D study chair
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Vs Host Disease, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Xu, M.D (+86 521 67780322, yangxu@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Complications (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.