Crohn Disease (CD)CONFORTNCT07471438
Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease.
A study testing MRI in people with Crohn Disease (CD), run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Apr 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 join
- Isolated colonic Crohn's disease
- Resection > 1 m of small intestine
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU d'Amiens
Amiens
- Not yet recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
About this study
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.
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.
Read the detailed description
This is a prospective, multicenter (5 centers), cross-sectional concordance study including adult patients with ileal and/or colonic Crohn's disease requiring MR enterography for reassessment of disease activity. Patients will undergo two MR enterography scans at 2 and 7 days intervals. The first scan will be performed without a distension agent, and the second with intestinal distension (as is standard practice). A gadolinium-based contrast agent will be used in both MR enterography scans. Furthermore, the MRI protocols and sequences will be identical. The images will be anonymized and uploaded to a dedicated platform for centralized review by two expert radiologists (randomly selected) blinded to clinical data. The primary endpoint will be the C-score (a quantitative variable), the concordance of which will be assessed using Lin's coefficient.
- Conditions
- Crohn Disease (CD)
- Being tested
- MRI
- Keywords
- Crohn Disease, MRI
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
All patients included in the study will undergo an MRI without contrast medium in order to compare the inflammatory damage visible on an MRI with contrast agent.
| Study group | Role | What they receive |
|---|---|---|
| MRI without a distension agent | Experimental | Patients with Crohn's disease will have an MRI without a contrast agent Receives: Procedure: MRI |
| MRI with a distension agent | Active comparator | Patients with Crohn's disease will have an MRI with a contrast agent Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Clermont score (C-Score)
quantitative variable, whose concordance will be assessed by Lin's coefficient.
Measured: From enrollement to the end of the follow up at 7th day
Secondary outcomes (6)
MaRIA score
quantitative variable, whose concordance will be assessed by Lin's coefficient
Measured: From enrollement to the end of the follow up at 7th day
Transmural inflammatory activity
defined by a C-score > 0.5, binary variable, whose concordance will be assessed by the kappa coefficient
Measured: From enrollement to the end of the follow up at 7th day
Numerical acceptability scale
Numerical acceptability scale from 0 to 10 (10 = perfect acceptability)
Measured: From enrollement to the end of the follow up at 7th day
Numerical scale for intestinal distension
Numerical scale from 0 to 10 (10 = perfect acceptability)
Measured: From enrollement to the end of the follow up at 7th day
Likert scale for intestinal distension quality
(0 = very poor, 1 = poor, 2 = fair distension, 3 = good distension, and 4 = excellent distension)
Measured: From enrollement to the end of the follow up at 7th day
Percentage of side effects of interest within 48 hours of the examination
(diarrhea, fecal urgency, change in stool consistency, vomiting, nausea)
Measured: After each MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start22 Apr 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All patients will have two MRI scans one week apart, one with and one without contrast agent.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony BUISSON, Professor, Principal investigator, cl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471438
- Sponsor's protocol ID
- PHRC I 2025 HORDONNEAU
- Acronym
- CONFORT
- Status last verified
- Jan 2026
- First submitted
- 10 Mar 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07471438
- Acronym / sponsor ID
- CONFORT / PHRC I 2025 HORDONNEAU
- Conditions
- Crohn Disease (CD)
- Keywords
- Crohn Disease, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, multicenter (5 centers), cross-sectional concordance study including adult patients with ileal and/or colonic Crohn's disease requiring MR enterography for reassessment of disease activity. Patients will undergo two MR enterography scans at 2 and 7 days intervals. The first scan will be performed without a distension agent, and the second with intestinal distension (as is standard practice). A gadolinium-based contrast agent will be used in both MR enterography scans. Furthermore, the MRI protocols and sequences will be identical. The images will be anonymized and uploaded to a dedicated platform for centralized review by two expert radiologists (randomly selected) blinded to clinical data. The primary endpoint will be the C-score (a quantitative variable), the concordance of which will be assessed using Lin's coefficient.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- All patients will have two MRI scans one week apart, one with and one without contrast agent.
| Arm | Type | Receives |
|---|---|---|
| MRI without a distension agent | Experimental | Procedure: MRIPatients with Crohn's disease will have an MRI without a contrast agent |
| MRI with a distension agent | Active comparator | Procedure: MRIPatients with Crohn's disease will have an MRI with a contrast agent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Isolated colonic Crohn's disease
- Resection > 1 m of small intestine
- Severe obstructive symptoms defined according to CDOS (Crohn's disease obstructive symptoms score)
- Uncontrolled intra-abdominal abscess
- Isolated anoperineal lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAll patients included in the study will undergo an MRI without contrast medium in order to compare the inflammatory damage visible on an MRI with contrast agent. | Procedure or surgery | MRI with a distension agent, MRI without a distension agent |
Primary outcome
Modified Clermont score (C-Score)
Time frame: From enrollement to the end of the follow up at 7th day
quantitative variable, whose concordance will be assessed by Lin's coefficient.
6 secondary outcomes
MaRIA score
Time frame: From enrollement to the end of the follow up at 7th day
Transmural inflammatory activity
Time frame: From enrollement to the end of the follow up at 7th day
Numerical acceptability scale
Time frame: From enrollement to the end of the follow up at 7th day
Numerical scale for intestinal distension
Time frame: From enrollement to the end of the follow up at 7th day
Likert scale for intestinal distension quality
Time frame: From enrollement to the end of the follow up at 7th day
Percentage of side effects of interest within 48 hours of the examination
Time frame: After each MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony BUISSON, Professor principal investigator
cl
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Crohn Disease (CD), run by University Hospital, Clermont-Ferrand at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Clermont score (C-Score) (time frame: From enrollement to the end of the follow up at 7th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.