Influence of Antimicrobial Drugs on Mycophenolic acid and Tacrolimus Pharmacokinetics and the Gut Microbiome in Kidney Transplant Recipients (AXIS)
People who have had a kidney transplant must take daily anti-rejection medicines, such as tacrolimus and mycophenolate mofetil, to protect their new organ. Because these medicines lower the immune system, transplant recipients sometimes need antibiotics or other antimicrobial treatments to fight off infections. However, infection-fighting drugs may affect how the body absorbs and processes anti-rejection medicines. They can also alter the natural, healthy bacteria living in the gut, which help break down medications. The AXIS study investigates how these treatments interact. By monitoring blood levels and testing stool samples, researchers aim to discover how gut bacteria and medicine levels shift during treatment. The goal is to provide doctors with clearer guidance on how to adjust medication doses safely whenever a transplant patient gets an infection.
At a glance
What is this study about?
A kidney transplant offers a fresh start, but it requires lifelong care. Patients must take daily anti-rejection medicines, such as tacrolimus (Prograf or Advagraf) and mycophenolate mofetil (CellCept), to keep their immune system from attacking the donor kidney. Because these drugs lower the immune system, transplant recipients are at higher risk of catching infections that require antibiotics or other antimicrobial medicines.
While antibiotics are vital for clearing up infections, they also wipe out many of the friendly bacteria living in our digestive tract, known as the gut microbiome. Scientists now know that these gut bacteria play an active role in how medicines are absorbed, activated, and removed from the body. If the balance of gut bacteria is disturbed by antibiotics, the amount of anti-rejection medicine in the bloodstream could unexpectedly rise or fall.
The AXIS study aims to understand this process in detail. Researchers are comparing drug levels in kidney transplant patients who are taking infection-fighting medicines with those who are not. They will also look at stool samples to see how gut bacteria change and examine how individual genetics influence the way these medicines are broken down.
This research is important because getting the dose of anti-rejection medicine just right is essential. Too much medicine can cause harmful side effects, while too little can lead to organ rejection. The findings will help doctors safely adjust medication doses whenever a transplant patient needs treatment for an infection.
Key takeaways
- The AXIS study investigates how infection-fighting drugs affect anti-rejection medicines in kidney transplant patients.
- Researchers want to see how antibiotics impact both drug levels in the blood and healthy gut bacteria.
- Participants continue to take their standard prescribed medicines, including tacrolimus and mycophenolate.
- Taking part involves blood tests to check medicine levels and providing stool samples to study gut bacteria.
- The goal is to help doctors prescribe safer, more precise doses of medicines when transplant patients get infections.
Who may be eligible?
This study is open to adults aged 18 and over who have received a kidney transplant and are currently taking standard anti-rejection medicines, specifically tacrolimus (such as Prograf or Advagraf) and mycophenolate mofetil (such as CellCept). Both men and women can join.
You may be considered if you are taking these medications and either need treatment with antimicrobial medicines (such as antibiotics) or are invited to take part as a comparison participant.
Your hospital transplant team will check your overall health, kidney function, and the full list of medicines you are taking to decide whether joining the study is safe and appropriate for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have had a kidney transplant.
- I take tacrolimus (Prograf or Advagraf) as an anti-rejection medicine.
- I take mycophenolate mofetil (CellCept) as an anti-rejection medicine.
- I am willing to provide blood and stool samples for research.
What does participation involve?
If you take part, you will continue taking your normal prescribed anti-rejection tablets, such as CellCept, Advagraf, or Prograf. You will not be asked to stop your vital treatments. Participation will mostly happen alongside your routine hospital clinic visits.
You will be asked to give blood samples at set times over a 12 to 24-hour period so the team can measure the exact levels of medicine in your body. You will also provide small stool (poo) samples so researchers can study your gut bacteria. In addition, a blood sample may be tested to look at genes that affect how your body breaks down drugs. The research team will explain the exact schedule and how long you will be involved before you decide to join.
Potential risks and benefits
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Common questions
Will I have to switch or stop my current transplant medicines?
No. You will continue taking your prescribed anti-rejection medicines as directed by your kidney doctor.
What is an antimicrobial drug?
Antimicrobial drugs are medicines used to treat infections. They include antibiotics (which fight bacteria) and antifungals (which fight fungal infections).
Why do the researchers need stool samples?
Stool samples allow scientists to study the natural bacteria living in your gut to see how they change when you take antibiotics and how they interact with your transplant medicines.
Is there a new, untested drug being tested on me?
No. This is an observational study using standard, approved medicines that transplant patients already take.
What happens if I decide I no longer want to take part?
You are free to leave the study at any point. Your decision will not affect the quality of your NHS care or your relationship with your doctors.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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