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NCT07471438Recruiting

Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease.

Study of Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease.

Source: ClinicalTrials.gov · Last updated 30 Jul 2026

Brief summary (registry, in English)

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). 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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
10 Mar 2026
Start date
22 Apr 2026
Primary completion date
Sept 2026
Lead sponsor
University Hospital, Clermont-Ferrand
NCT number
NCT07471438

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 22 Apr 2026 to the primary completion date, Sept 2026
  • 2 sites 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

  • Resection \> 1 m of small intestine

Other illness

  • Isolated colonic Crohn's disease
  • Severe obstructive symptoms defined according to CDOS (Crohn's disease obstructive symptoms score)

Other

  • 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)

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU D'amiens
Coordinator of this site? Confirm its status
AmiensFranceRecruiting
CHU de Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.