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Can your gut bacteria change how transplant drugs work?

NCT ID NCT04953715

Knowledge-focused Sponsor: The University of Texas Medical Branch, Galveston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study looks at how the natural bacteria in the body (the microbiome) interact with immunosuppressant drugs taken by kidney transplant recipients. Researchers will collect samples from the gut, mouth, nose, and urine to see if the microbiome influences how the body processes these medications. The goal is to understand why some people experience side effects like diarrhea and how drug levels vary, which could lead to better personalized treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
No intervention; observational study of microbiome and immunosuppressant metabolism
What this could lead to
Could reveal how gut bacteria influence transplant drug processing, potentially improving personalized dosing and reducing side effects.
What could go wrong
As an observational study, it cannot prove cause and effect; findings may not lead to immediate clinical changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2020

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults kidney transplant recipients with a planned immunosuppression regimen of mycophenolate mofetil dosed every 12 hours and immediate release tacrolimus dosed twice daily.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney transplant Kidney transplant rejection

Contacts and locations

Locations

  • HCMC

    Minneapolis, Minnesota, 55415, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55414, United States

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