Microbiome and Immunosuppression: The Mission Study (MISSION)

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: Kidney Transplant Rejection; Kidney Transplant
• Intervention / Treatment: Other: collection of body microbiome

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

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • HCMC

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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.

Other: collection of body microbiome; 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.	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.	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

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Ajay Israni, MD, University of Texas Medical Branch, Galveston

Study record dates

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): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Microbiome; transplant; kidney
• Other Study ID Numbers: 24-0273; "MISSION" study (Other Identifier: Hennepin Healthcare Research Institute); R01AI140303 (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