Microbiome and Immunosuppression: The Mission Study (MISSION)
August 4, 2026 updated by: The University of Texas Medical Branch, Galveston
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Immunosuppression drugs, like antibiotics and certain foods, can change the microbiome (the natural micro-organisms inside the body) of the individual taking the drug. The study team wants to study what impact these changes to the microbiome have on the individual. The study team is specifically interested in how these changes to the microbiome may change the metabolism (breakdown) and action of medications. It is already known that individual genetics impact the metabolism, absorption, and toxicities of some medications. It is suspected that the microbiome will have similar impacts on medications. With a better understanding of how individual microbiome impacts immunosuppressant medications used to help transplant recipients from rejecting their new organs, providers can more accurately prescribe and dose these medications to better treat and care for transplant patients and their organs.
It is expected that participants will be in this research study for up to 12 years. There will be periods of time that requires active participation (visits) and periods of time that will be more passive participation (allowing study staff to follow-up with medical records for outcomes).
Study Type
Observational
Enrollment (Estimated)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55414
- University of Minnesota
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Minneapolis, Minnesota, United States, 55415
- HCMC
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adults kidney transplant recipients with a planned immunosuppression regimen of mycophenolate mofetil dosed every 12 hours and immediate release tacrolimus dosed twice daily.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1 - This is a multicenter microbiome and pharmacokinetic study.
A prospective, observational microbiome study of adult kidney transplant recipients receiving mycophenolate mofetil and tacrolimus maintenance immunosuppression.
Participants will be studied post-transplant for mycophenolate pharmacokinetics and microbiome samples collected.
Clinically measured tacrolimus trough concentrations will also be evaluated.
Associations among mycophenolic acid enterohepatic recycling and metabolite formation, tacrolimus troughs, immunosuppression adverse effects, diarrhea and microbiome will be studied.
To assess the relationship between kidney graft outcomes and stool, oral, nasal and urine microbiome diversity.
To assess the relationship between transplant graft outcomes and urinary transcriptome.
|
A prospective, observational microbiome study of adult kidney transplant recipients receiving mycophenolate mofetil and tacrolimus maintenance immunosuppression.
Participants will be studied post-transplant for mycophenolate pharmacokinetics and microbiome samples collected.
Clinically measured tacrolimus trough concentrations will also be evaluated.
Associations among mycophenolic acid enterohepatic recycling and metabolite formation, tacrolimus troughs, immunosuppression adverse effects, diarrhea and microbiome will be studied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To assess the relationship between transplant graft outcomes and urinary transcriptome.
Time Frame: 5 years
|
The gut microbiome has been implicated in the Stool from tx recipients with diarrhea is often sent for testing of potential pathogenic organisms.
polymerase chain reaction (PCR)- based approaches to identify etiology of post-tx diarrhea only tests for a limited number of organisms.
|
5 years
|
|
To assess the relationship between kidney graft outcomes and stool, oral, nasal, and urine microbiome diversity.
Time Frame: 5 years
|
The gut microbiome has been implicated in the variability in metabolism of drugs with specific microbial species being associated with direct and indirect effects.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ajay Israni, MD, University of Texas Medical Branch, Galveston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mohamed ME, Saqr A, Onyeaghala G, Remmel RP, Staley C, Dorr CR, Teigen L, Guan W, Vo D, El-Rifai R, Oetting WS, Matas AJ, Israni AK, Jacobson PA. A Mycophenolate Pharmacokinetic Study with New Insights into Enterohepatic Recirculation in Kidney Transplant Recipients. Clin Pharmacokinet. 2026 Mar;65(3):479-495. doi: 10.1007/s40262-025-01611-3. Epub 2026 Feb 6.
- Mohamed ME, Saqr A, Onyeaghala G, Remmel RP, Staley C, Dorr CR, Teigen L, Guan W, Madden H, Munoz J, Sanchez B, Vo D, El-Rifai R, Oetting WS, Matas AJ, Israni AK, Jacobson PA. Simultaneous Prediction of Area Under the Curves of Mycophenolic Acid and Its Metabolites and Enterohepatic Recirculation in Kidney Transplant Recipients. Ther Drug Monit. 2025 Dec 1;47(6):799-808. doi: 10.1097/FTD.0000000000001336. Epub 2025 Apr 30.
- Mohamed ME, Saqr A, Al-Kofahi M, Onyeaghala G, Remmel RP, Staley C, Dorr CR, Teigen L, Guan W, Madden H, Munoz J, Vo D, Sanchez B, El-Rifai R, Oetting WS, Matas AJ, Israni AK, Jacobson PA. Limited Sampling Strategies Fail to Accurately Predict Mycophenolic Acid Area Under the Curve in Kidney Transplant Recipients and the Impact of Enterohepatic Recirculation. Ther Drug Monit. 2025 Feb 1;47(1):174-182. doi: 10.1097/FTD.0000000000001248. Epub 2024 Jul 23.
- Khan MH, Onyeaghala GC, Rashidi A, Holtan SG, Khoruts A, Israni A, Jacobson PA, Staley C. Fecal beta-glucuronidase activity differs between hematopoietic cell and kidney transplantation and a possible mechanism for disparate dose requirements. Gut Microbes. 2022 Jan-Dec;14(1):2108279. doi: 10.1080/19490976.2022.2108279.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 12, 2020
Primary Completion (Estimated)
January 1, 2032
Study Completion (Estimated)
January 1, 2033
Study Registration Dates
First Submitted
June 28, 2021
First Submitted That Met QC Criteria
July 2, 2021
First Posted (Actual)
July 8, 2021
Study Record Updates
Last Update Posted (Actual)
August 7, 2026
Last Update Submitted That Met QC Criteria
August 4, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 24-0273
- "MISSION" study (Other Identifier: Hennepin Healthcare Research Institute)
- R01AI140303 (U.S. NIH Grant/Contract)
- K01AI199717-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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