Evaluation of the efficacy of topical treatment with budesonide in children with Crohn's disease located in the esophagus and/or stomach and/or duodenum - BETHESDa
The BETHESDa study is an important research project helping us understand how to best treat Crohn's disease in children when it affects their food pipe (oesophagus), stomach, or the very first section of their small bowel (duodenum). Doctors are testing a specific medicine called budesonide, which is given topically, meaning it’s applied directly to the affected area. The main goal is to see how many children no longer have signs of inflammation when doctors look inside with a camera (endoscopy) and examine tiny tissue samples (histopathology). This is a Phase III study, which means it's one of the final steps before a treatment might be widely used, confirming if it's both safe and effective.
At a glance
What is this study about?
This study, called BETHESDa, is looking at a common condition in children called Crohn's disease. Crohn's disease is a long-lasting condition where parts of the digestive system become inflamed and swollen. While it most often affects the small or large bowel, it can also show up in the food pipe (oesophagus), stomach, or the very first part of the small bowel (duodenum).
The main aim of this study is to see how well a specific medication, called budesonide, works when applied directly to these areas. Budesonide is a type of steroid that helps reduce inflammation. Doctors will check if giving budesonide this way can help clear up the inflammation seen during a camera examination (endoscopy) and also when they look at tiny tissue samples under a microscope (histopathology).
By taking part, children could help doctors understand if this way of treating Crohn's disease in the upper digestive system is effective. This research is important because it could lead to better treatments for children with this type of Crohn's, improving their health and quality of life.
Key takeaways
- This study focuses on Crohn's disease in children affecting the food pipe, stomach, or first part of the small bowel.
- It's testing a specific anti-inflammatory drug called budesonide.
- The main goal is to see if the treatment can make signs of the disease disappear.
- This is a Phase III study, which helps confirm the treatment's effectiveness.
- Children of all ages, both boys and girls, with this type of Crohn's disease can be considered.
Who may be eligible?
This study is open to both boys and girls of all ages who have Crohn's disease affecting their food pipe (oesophagus), stomach, or the first part of their small bowel (duodenum).
If your child has been diagnosed with Crohn's disease in these specific areas, they might be able to take part. The research team will need to confirm the diagnosis and check other details to make sure the study is suitable for your child.
There aren't any age limits mentioned, meaning children and teenagers of various ages are being considered for this important research.
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.
- Does your child have Crohn's disease?
- Does their Crohn's disease affect their food pipe (oesophagus), stomach, or duodenum (first part of small bowel)?
- Are you comfortable with them taking new medications as part of a study?
- Are you happy for them to have regular check-ups, including camera tests if needed?
What does participation involve?
If your child decides to take part in this study, they will receive specific medications to treat their Crohn's disease. One medication is Ultop, which is a capsule, and the other is Budixon Neb, a liquid that might be given as a mist (nebulisation). Over a period, the study team will carry out several checks. This includes repeat camera examinations (endoscopies) and taking small tissue samples (biopsies) to see if the treatment is working.
The study will also involve regular checks on your child's symptoms and how they are feeling, including whether they experience any side effects from the medication. Visits are planned at specified times, such as at 4, 8, and 12 weeks, to monitor progress and assess the impact of the treatment. The total duration of active participation and follow-up will be explained by the study team during the consent process.
Potential risks and benefits
Locations (1)
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Common questions
What is Crohn's disease?
Crohn's disease is a long-lasting condition that causes swelling and irritation in your digestive system, which can lead to tummy pain, diarrhoea, and weight loss.
What does 'topical treatment' mean?
It means the medicine is applied directly to the affected area, rather than being swallowed and working throughout the whole body.
What is budesonide?
Budesonide is a type of steroid medicine that helps reduce inflammation. It's often used for conditions like Crohn's disease.
What is an endoscopy?
An endoscopy is a procedure where a doctor uses a thin, flexible tube with a camera to look inside your body, like the food pipe, stomach, or bowel.
Will my child still receive their usual care if they join?
Yes, joining a study won't stop your child from receiving the best medical care; it's an addition to it.
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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