Medical Treatment Versus Surgery in Stricturing Small Bowel Crohn's Disease (NCT05584228) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Medical Treatment Versus Surgery in Stricturing Small Bowel Crohn's Disease
France150 participantsStarted 2026-10-01
Plain-language summary
The objective of the SMART trial is to compare a combination therapy using azathioprine and subcutaneous infliximab versus ileocecal resection in patients with symptomatic small bowel Crohn's disease.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 and 70 years
* Male or female
* Documented small bowel CD with intestinal stricture(s) identified on CT, MRI or endoscopy, AND responsible for obstructive symptoms
* CREOLE score \> 2
Exclusion Criteria:
* Adults under guardianship, safeguard justice or trusteeship
* Pregnant or breastfeeding female
* Acute bowel obstruction requiring urgent surgical intervention
* Suspected or confirmed gastrointestinal perforation
* Concurrent active perianal sepsis
* Internal fistulizing disease in association with strictures
* Colonic stenosis and/or colonic active disease at screening endoscopy
* Contra-indication to surgery, general anesthesia, anti-TNF, thiopurines
* Use of corticosteroids (prednisolone \> 20 mg daily or equivalent) within 4 weeks prior to visit V0
* Treatment with any biologics within 8 weeks before visit V0
* Presence of a stoma
* HIV/HCV/HBV infection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
IBD (inflammatory bowel disease) - related quality of life