A clinical trial comparing how the body takes up budesonide from different forms of medicine when taken by mouth with or without food.
Eosinophilic oesophagitis is a condition where the food pipe (the tube connecting your mouth to your stomach) becomes swollen and irritated, making swallowing difficult. Budesonide is an established anti-inflammatory medicine that can help soothe this swelling. This early research study (Phase I) is testing how budesonide enters the bloodstream when taken by mouth in different forms—such as liquids, dissolving tablets, or capsules. It also checks whether having a meal before taking the medicine affects how the body absorbs it. The trial is open to adults aged 18 and over. By taking part, volunteers help researchers understand the most effective ways to give budesonide in the future. Because this is an early pharmacology study, the main goal is to measure medicine levels in the body rather than provide a long-term cure.
At a glance
What is this study about?
Eosinophilic oesophagitis is an allergic condition that causes swelling and inflammation in the gullet (food pipe). For people living with it, eating can feel uncomfortable or painful, and food can sometimes get stuck. Doctors often treat this condition with steroids like budesonide, which act locally on the lining of the food pipe to calm down the inflammation.
Even though budesonide is already used as a medicine, scientists are constantly looking for ways to improve how it is given. Different forms of a medicine—such as tablets that melt in the mouth, liquids, or special mixtures—might stick to the food pipe better or be absorbed differently by the body. Food in the stomach can also change how fast or how well a medicine gets absorbed.
This study compares these different forms directly. Researchers will give participants the medicine either after fasting or with a meal, and then carefully measure how much of the drug passes into the body. This helps doctors work out the best instructions for future patients.
Understanding these details is an essential step in medical research. It ensures that treatments for eosinophilic oesophagitis are as reliable, safe, and convenient as possible for everyday life.
Key takeaways
- Tests how the body takes up the anti-inflammatory medicine budesonide.
- Compares different oral forms of the drug and looks at the effect of food on absorption.
- Open to adults aged 18 and over with eosinophilic oesophagitis.
- Involves clinic visits, set meal schedules, and blood tests to measure medicine levels.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and older of any sex. Because this is an early pharmacology trial, researchers are looking for individuals who can safely take budesonide and attend the required clinic visits.
While anyone over 18 may be considered, the study team will check your general medical background. You may not be able to join if you have certain active infections, significant liver or kidney problems, or known allergies to steroid medications like budesonide.
The trial team will carry out standard health checks, such as routine blood tests and medical history reviews, to confirm whether taking part is safe and suitable 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 been diagnosed with, or am being evaluated for, eosinophilic oesophagitis.
- I am able to swallow oral medicines (such as liquids or dissolving tablets).
- I am willing to attend clinic visits and have routine blood samples taken.
- I do not have a known allergy to budesonide or steroid medicines.
What does participation involve?
If you take part, you will be invited to a clinical trial unit for several visits. During these visits, you will take different oral forms of budesonide under medical supervision. On some visit days, you will take the medicine on an empty stomach, while on others, you will take it after eating a set meal. The medical team will take regular, small blood samples across several hours to measure how much medicine is in your system. You will also have simple health checks, such as blood pressure measurements and questions about how you feel. The study team will explain the exact schedule and total number of weeks involved before you agree to join.
Potential risks and benefits
Locations (1)
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Common questions
What is eosinophilic oesophagitis?
It is an allergic reaction in the food pipe (gullet) that leads to swelling, making it hard or uncomfortable to swallow food.
What is budesonide?
Budesonide is an anti-inflammatory medicine (a steroid) commonly used to calm swelling in the gut, lungs, and food pipe.
Why test the medicine with and without food?
Food can change how quickly a medicine is digested and absorbed, so researchers need to know if patients should take it on an empty stomach or with meals.
Will taking part cure my condition?
No, this is an early study designed to measure how the medicine moves through the body, rather than provide long-term treatment.
Can I leave the trial if I change my mind?
Yes, taking part is entirely voluntary. You can stop at any time without it affecting your normal medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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