Gut Microbiome Analysis in Organ Transplant Recipient (NCT06405958) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Gut Microbiome Analysis in Organ Transplant Recipient
200 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.