VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
This research is for adults with moderately to severely active Crohn's disease. Doctors want to find out if aiming for 'transmural healing' (where the bowel wall completely heals, inside and out) leads to better long-term outcomes. Currently, this healing isn't a standard treatment goal. The study uses a simple, non-invasive scan called intestinal ultrasound to check for this healing. Participants will be split into two groups. One group will have their treatment guided by this ultrasound healing, plus their symptoms and blood tests. The other group will have treatment guided by symptoms and blood tests only. The goal is to see if adding the ultrasound healing target helps more people achieve long-lasting remission from their Crohn's disease.
At a glance
What is this study about?
If you have Crohn's disease, you know it can cause inflammation deep within your digestive system. While current treatments often focus on reducing symptoms and inflammation you can see with an endoscopy (a camera test), this study is looking at an exciting new idea called 'transmural healing'. This means healing all layers of the bowel wall, not just the surface. Imagine a bruise healing not just on the outside, but all the way through – that's the idea here. Doctors believe achieving this deeper healing might lead to better, longer-lasting relief from Crohn's symptoms and possibly prevent future problems.
To check for this deeper healing, the study uses a special type of scan called an intestinal ultrasound. This is a gentle, safe, and patient-friendly way to look at the bowel wall thickness from outside your body, without needing invasive procedures like colonoscopies every time. This research wants to see if guiding your treatment based on what these ultrasounds show, along with how you feel and what your blood tests say, is more effective than just focusing on your symptoms and blood tests alone.
Essentially, the study is comparing two approaches: one where doctors actively try to achieve this full bowel wall healing seen on ultrasound, and another where they follow the usual approach of only monitoring symptoms and blood tests. Everyone in the study will receive treatment, and the main question is which approach helps people achieve lasting remission from their Crohn's disease more successfully, without needing steroids.
Key takeaways
- This study explores a new way to treat Crohn's disease by aiming for deeper bowel healing.
- It uses a gentle scan called intestinal ultrasound to check for this healing.
- Participants will be randomly assigned to one of two treatment guidance groups.
- The goal is steroid-free remission for people with moderately to severely active Crohn's.
- Treatment guidance could potentially lead to better long-term results.
Who may be eligible?
This study is looking for adults aged 18 to 80 years who have been diagnosed with moderately to severely active Crohn's disease. This means your Crohn's is currently causing significant symptoms and inflammation. Doctors will check this using specific scores and tests.
You might be able to join if you haven't been treated with strong biologic medicines before, or if you've only used a maximum of one type of these advanced treatments in the last five years. It's important that your disease is affecting certain parts of your bowel that can be seen by the special ultrasound used in the study.
However, you won't be able to join if you've had certain treatments in the past (like vedolizumab, etrolizumab, or natalizumab), or if you've used two or more different types of advanced biologic medicines. Also, if your Crohn's has led to certain complications like severe blockages in your bowel, or if your steroid dose has changed recently or is very high, this study might not be 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.
- Are you between 18 and 80 years old?
- Have you been told you have moderately to severely active Crohn's disease?
- Have you used no more than one advanced biologic therapy for Crohn's in the last 5 years (or none at all)?
- Are you able to attend regular hospital visits for check-ups and scans?
- Are you currently not on a very high dose of steroids or had a recent change to your steroid dose?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of two treatment groups, like flipping a coin. You won't get to choose which group you're in. Both groups will receive treatment over 48 weeks (about 11 months). During this time, you'll have regular hospital visits for check-ups, scans (including the intestinal ultrasound), blood tests, and to discuss your symptoms.
One group will have their treatment adjusted based on their intestinal ultrasound results, how they feel, and blood test markers. The other group will have their treatment adjusted based on how they feel and blood test markers only. Throughout the study, the aim is to get you into remission without needing steroids. The study compares which approach is better at achieving this. The total duration of active study treatment is 48 weeks.
Potential risks and benefits
Locations (69)
- TLC Clinical Research Inc - Los AngelesVerified postcodeLos Angeles, United States· Withdrawn
- Medical University of South Carolina (MUSC)Verified postcodeCharleston, United States· Not yet recruiting
- Houston Methodist HospitalVerified postcodeHouston, United States· Recruiting
- Concord Repatriation General HospitalVerified postcodeConcord, Australia· Recruiting
- Mater Misericordiae LtdVerified postcodeSouth Brisbane, Australia· Recruiting
- Calvary Adelaide HospitalVerified postcodeAdelaide, Australia· Recruiting
- Royal Adelaide HospitalVerified postcodeAdelaide, Australia· Recruiting
- The Queen Elizabeth HospitalVerified postcodeWoodville, Australia· Recruiting
- Northern Hospital EppingVerified postcodeEpping, Australia· Recruiting
- Austin HealthVerified postcodeHeidelberg, Australia· Recruiting
- The Alfred HospitalVerified postcodeMelbourne, Australia· Recruiting
- Royal Melbourne HospitalVerified postcodeMelbourne, Australia· Recruiting
Common questions
What is 'transmural healing'?
It means the deep healing of all layers of your bowel wall, not just the surface. Doctors hope this leads to longer-lasting relief from Crohn's.
What is an intestinal ultrasound?
It's a gentle, non-invasive scan (like an ultrasound for pregnancy) that looks at the thickness and health of your bowel from outside your body.
Will I receive new medicine in this study?
The study focuses on how existing treatments are guided. You will receive treatment, but the new part is how doctors decide to adjust it based on your progress.
How long will the study last if I join?
The active treatment phase of the study will last for 48 weeks, which is about 11 months.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time, for any reason, without affecting your medical care.
How to find out more
Elena van Hest
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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