Comparing bowel MRI with and without an intestine-stretching drink in Crohn's disease
Tests bowel MRI without a stretching drink in people with ileal Crohn's disease.
Key facts
- Who runs it
- University Hospital, Clermont-Ferrand
- Where
- Amiens and Clermont-Ferrand, FranceSee the 2 sites
- Trial code
- Registry title
- Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease.
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 22 Apr 2026
- Planned end
- Sept 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- MRI
- Record updated
- 30 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Crohn's disease in the ileum who need a check of their gut inflammation. Each person has two MRI scans in one week.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Crohn's disease with known or suspected involvement of the ileum, with or without the colon, needing a new check of inflammation.
Main reasons for not taking part
- Crohn's disease of the colon only
- Removal of more than 1 m of small intestine
- Severe blockage symptoms
- Abscess in the abdomen that is not under control
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Patients with Crohn's disease according to European recommendations (ECCO) ≥ 18 years of age
- With known or suspected ileal ± colonic involvement
- Requiring reassessment of disease inflammatory activity according to the clinician
- Able to give informed consent to participate in the research
- Affiliation with a Social Security scheme
- Agreeing to undergo two MRIs in the same week
Who cannot take part
- Resection > 1 m of small intestine
- Isolated colonic Crohn's disease
- Severe obstructive symptoms defined according to CDOS (Crohn's disease obstructive symptoms score)
- Uncontrolled intra-abdominal abscess
- Isolated anoperineal lesions
- Prevention of postoperative endoscopic recurrence
- Temporary or permanent stoma
- Total colectomy
- Contraindication to MRI
- Pregnant or breastfeeding women
- Protected adults (under guardianship, trusteeship, family authorization, future protection mandate, with representation relating to the person)
Where in France
- CHU D'amiensAmiens, FranceContact: Lise LaclautreTaking people
- CHU de Clermont-FerrandClermont-Ferrand, FranceContact: Lise LaclautreNot yet recruiting
About the trial
What the trial wants to find out
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can significantly impair patients' quality of life. Due to its transmural nature (affecting the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula), requiring intestinal resection in approximately half of patients during follow-up. The long-term goal for patients is to maintain a normal life, i.e., without symptoms and without intestinal destruction. To this end, short- and medium-term therapeutic goals have evolved in recent years. Clinical remission is not a sufficient goal, as it has not changed the natural history of the disease. The current goal is to achieve a combination of clinical remission and endoscopic mucosal healing, as this is associated with a reduced risk of adverse outcomes (recurrence of symptoms, hospitalization, intestinal resection).
Read full original descriptionShow less
Transmural healing assessed by MRI is also a promising goal associated with a reduced risk of adverse outcomes (recurrence of symptoms, hospitalization, intestinal resection). Furthermore, it is associated with a lower risk of progression to intestinal destruction, unlike endoscopic remission. In this context, transmural healing could soon become the benchmark in terms of therapeutic objectives for Crohn's disease, particularly in the ileum. Although enteric MRI is better accepted than colonoscopy by patients with Crohn's disease, in the ACCEPT1 study, nearly half of patients (48.6%) reported the need to use an intestinal distension product (PEG, mannitol, etc.) as a significant obstacle to repeating entero-MRI, while more than a third complained of vomiting (33.7%) or severe diarrhea (35.0%) induced by these same products. Being able to do without the use of distension products would significantly improve the acceptability of entero-MRI.
The investigators hypothesize that an enteric MRI without distension would lead to poorer ileal distension but would allow inflammatory activity scores to be assessed on MRI in a manner similar to an examination with distension, and thus would not impact the need for therapeutic intensification.
The 2 groups in the trial
- MRI without a distension agentTreatment being tested
Patients with Crohn's disease will have an MRI without a contrast agent
Treatment: MRI
- MRI with a distension agentExisting treatment, for comparison
Patients with Crohn's disease will have an MRI with a contrast agent
Treatment: MRI
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Study of Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease.
- Plain-language title
- Comparing bowel MRI with and without an intestine-stretching drink in Crohn's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 30 July 2026