Microbiome and Immunosuppression: The Mission Study (NCT04953715) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Microbiome and Immunosuppression: The Mission Study
United States140 participantsStarted 2020-02-12
Plain-language summary
The purpose of this research is to study immunosuppression drugs, certain foods, and how they can change the microbiome (the natural microorganisms inside the body) of the individual taking the immunosuppressive medications. The study team wants to study how the microbiome affects how the body processes the transplant medication.
Who can participate
Age range
18 Years
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:
* Participants undergoing kidney transplant
* Male or female at least 18 years of age at time of enrollment
* Will or have received a living or deceased donor kidney transplant
* Planned post-transplant immunosuppression regimen of mycophenolate mofetil dosed every 12 hours (Cellcept or generic) and immediate release tacrolimus dosed twice daily with trough concentration monitoring (generic or brand formulation).
* Able and willing to complete study-related procedures and visits
* Signs written informed consent
Exclusion Criteria:
* Recipient of a previous non-kidney transplant
* Subject is a multi-organ transplant recipient
* Presence of active gastroparesis, and documented in the medical record
* Liver dysfunction (total bilirubin \>2x upper limit of normal) within 2 months of enrollment
* Patients who take medications that significantly inhibit uridine 5'-diphosphate glucuronosyltransferase (UGT) enzymes.
* Patients who take medications that significantly inhibit or induce the biliary transporters
* Patient is known to be HIV positive
* Pregnant or nursing (lactating) women
* Non-English speaking
* Patients who have undergone bariatric surgery
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.
What they're measuring
1
To assess the relationship between transplant graft outcomes and urinary transcriptome.
Timeframe: 5 years
2
To assess the relationship between kidney graft outcomes and stool, oral, nasal, and urine microbiome diversity.
Timeframe: 5 years
Trial details
NCT IDNCT04953715
SponsorThe University of Texas Medical Branch, Galveston