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Recruiting NCT06452550

Neurophenotype Predicts CD Disease Progression

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Trial Parameters

Condition Radiomics
Sponsor First Affiliated Hospital, Sun Yat-Sen University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 18 Years
Max Age 45 Years
Start Date 2021-05-01
Completion 2025-06-01
Interventions
Logistic regression (LR) prediction models

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Brief Summary

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

Inclusion Criteria: * (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. Exclusion Criteria: * (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.

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