Microbiome and Immunosuppression: The Mission Study
Running, not enrolling
Conditions studied: Kidney Transplant Rejection, Kidney Transplant
In brief
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.
Key facts
- Study ID
- NCT04953715
- Run by
- The University of Texas Medical Branch, Galveston
- People needed
- 140
- Starts
- 2020-02-12
- Expected to finish
- 2033-01-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States
- HCMC — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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