Neurophenotype Predicts CD Disease Progression
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
About this trial
The goal of this observational study is aimed to develop a novel multimodal neuroimaging-based model to characterize the neurophenotype of Crohn's Disease patients and assess its ability for predicting disease progression, using multiomics data to interpret the model.
Participants will be followed-up of at least six months for patients without disease progression to assess the relationship between neurophenotype and intestinal outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
(a) CD patients aged 18-45 years; (b) the completion of multimodal brain MRI and administration of psychological questionnaires; (c) MR enterography (MRE), ileocolonoscopy, and blood or faecal samples, collection within one week of brain MRI; (d) a follow-up of at least six months for patients without disease progression; and (e) right-handedness.
Disqualifiers
(a) recent use of antibiotics, probiotics, or prebiotics within three months prior to inclusion; (b) history of neurosurgery, cerebrovascular disease, or brain trauma; (c) use of central nervous system drugs or antidepressants within three months prior to inclusion; (d) identification of brain lesions on MR scan; (e) claustrophobia; or (f) presence of metal implants.
Trial population
This study included adult patients aged 18 to 45 with Crohn's disease (CD) who were admitted to the First Affiliated Hospital of Sun Yat-sen University between May 2021 and June 2025.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Logistic regression (LR) prediction models
Diagnostic testLogistic regression model was used to establish a model to distinguish different levels of intestinal inflammation.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Crohn's disease patients with no-to-mild inflammation1 intervention
Group B: Crohn's disease patients with moderate-to-severe inflammation1 intervention
Trial outcomes
Primary outcomes
1
The area under the ROC curve (AUC) to assess the performance of diagnostic model
After baseline brain MRI scanning, patients were followed up.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov