Medical Treatment Versus Surgery in Stricturing Small Bowel Crohn's Disease

Starting soon · Not applicable

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT05584228

Run by

Nantes University Hospital

People needed

150

Starts

2026-10-01

Expected to finish

2031-04-01

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHU de Nantes — Nantes, France

Full record on ClinicalTrials.gov

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