NCT05584228Not yet recruiting
Medical Treatment Versus Surgery in Stricturing Small Bowel Crohn's Disease
SyMptomAtic Stricturing Small Bowel CRohn's Disease - Medical Treatment Versus Surgery, a Prospective, Multi-centre, Randomized, Non-inferiority Trial
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 26 Sept 2022
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Apr 2030
- Lead sponsor
- Nantes University Hospital
- Diseases
- Crohn's disease
- NCT number
- NCT05584228
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Oct 2026 to the primary completion date, 1 Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute bowel obstruction requiring urgent surgical intervention
- Concurrent active perianal sepsis
- 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
Other illness
- Suspected or confirmed gastrointestinal perforation
- Internal fistulizing disease in association with strictures
- Colonic stenosis and/or colonic active disease at screening endoscopy
- HIV/HCV/HBV infection
Other
- Adults under guardianship, safeguard justice or trusteeship
- Pregnant or breastfeeding female
- Presence of a stoma
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.