Gut Microbiome Analysis in Organ Transplant Recipient

NCT06405958 | Not Yet Recruiting DMC

• 1 other identifier: S2024-0859-0001
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The microbiome acts as an antigen and can induce signaling through receptors like TLRs and NODs. Microbial metabolites can directly act on gut cells or reach other organs systemically. Studies show that the commensal, non-pathogenic microbiota plays an important role in regulating the immune system in various ways:

• Promoting differentiation of Th17 cells and ILC3 signaling to regulate IL-17A production
• Influencing iNKT cell generation early in life to prevent inflammatory activities
• Facilitating CD4+ T cell differentiation and balancing Th1/Th2 responses
• Inducing regulatory T cells (Tregs) that promote immune homeostasis
• Tregs in Peyer's patches help maintain a microbiome that supports homeostasis The microbiome influences T cells, B cells and immune homeostasis. This has implications for transplantation, where modulating the microbiome could impact the graft's acceptance by affecting the recipient's immune cells that respond to the transplant. In summary, it highlights the microbiome's role in immune regulation and the potential for leveraging this interaction therapeutically, including in the context of transplantation.

Conditions

Microbial Colonization

Keywords

microbiota; solid organ transplantation; metagenomic sequencing

Outcome Measures

Primary Outcomes (1)

• Changes in the gut Microbiome

  Collecting admission and regular stool samples from solid organ transplant recipients (liver, kidney, heart, pancreas, lung) and performing high-resolution microbiome analysis (based on 16S full-length sequencing) to investigate changes in the gut microbiome following transplantation and develop models to predict outcomes in these patients.

  3 years

Study Arms (5)

Liver transplant patients

Patients who have undergone liver transplantation

Other: gut microbiome

Kidney transplant patients

Patients who have undergone kidney transplantation

Other: gut microbiome

Pancreas transplant patients

Patients who have undergone pancreas transplantation

Other: gut microbiome

Heart transplant patients

Patients who have undergone heart transplantation

Other: gut microbiome

Lung transplant patients

Patients who have undergone lung transplantation

Other: gut microbiome

Interventions

gut microbiome OTHER

Obtaining new gut microbiome data in organ transplantation

Heart transplant patients; Kidney transplant patients; Liver transplant patients; Lung transplant patients; Pancreas transplant patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For liver transplant patients, 90 samples are expected with stool, blood, and saliva collection at baseline, 1 month, and 6-12 months post-transplant. 16S full-length sequencing will be performed on these samples. For kidney transplant recipients, 70 stool samples will undergo the same collection timing and 16S analysis. Heart transplant patients will contribute 10 stool samples following the same timepoints for 16S sequencing and RNA sequencing. Lung transplant recipients will provide 15 stool and blood samples at those timepoints for 16S full-length and RNA sequencing analysis. Finally, 15 stool and blood samples will be collected from pancreas transplant recipients per the stated schedule for 16S analysis only. The comprehensive sampling strategy across different organ groups aims to characterize microbiome and transcriptomic changes over the transplant period using appropriate molecular profiling methods.

You may qualify if:

• Patients who have received or are receiving solid organ transplants (liver, kidney, pancreas, heart, lung) at this hospital.
• Patients who have listened to and understood a detailed explanation of this study, and have voluntarily decided to participate and provided written consent.

You may not qualify if:

• Patients undergoing re-transplantation.
• Patients with a history of previous organ transplantation, except for cases where a pancreas transplant is performed after a kidney transplant.

Sponsors & Collaborators

• Asan Medical Center: lead

Biospecimen

Retention: SAMPLES WITH DNA

Enrollment of liver, kidney, heart, pancreas, and lung solid organ transplant recipients and regular collection of stool samples (at the time of transplantation, 1 month, 6\~12months after transplantation)

MeSH Terms

Conditions

Communicable Diseases

Interventions

Gastrointestinal Microbiome

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microbiota; Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 9, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 28, 2024

Record last verified: 2024-05