Medical Treatment Versus Surgery in Stricturing Small Bowel Crohn's Disease
Not applicable · Testing Azathioprine + infliximab and Intestinal resection · 1 site · Nantes University Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Azathioprine + infliximab (a drug) and Intestinal resection (a procedure) as a possible treatment. Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 150 participants are expected to take part.
- Start date: 2026-10-01 (planned).
- Main results expected around 2030-04-01 (estimate from the record).
- 1 study site listed in France.
Main thing being measured
- IBD (inflammatory bowel disease) - related quality of life (12 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Nantes University Hospital |
| Collaborators | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
| Enrollment | 150 (estimated) |
| Start date | 2026-10-01 |
| Primary completion (est.) | 2030-04-01 |
| First posted | 2022-10-18 |
| Last updated | 2026-06-23 |
| Official title | SyMptomAtic Stricturing Small Bowel CRohn's Disease - Medical Treatment Versus Surgery, a Prospective, Multi-centre, Randomized, Non-inferiority Trial |
| ClinicalTrials.gov ID | NCT05584228 |
Interventions
- Azathioprine + infliximab (Drug)
Combination therapy using 2-2.5 mg/kg oral azathioprine plus subcutaneous infliximab - Intestinal resection (Procedure)
Ileocolonic or small bowel resection
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nantes | Nantes | France |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.