Neurophenotype Predicts CD Disease Progression

Recruiting

• Conditions: Radiomics; Multi-omics

• Registration Number: NCT06452550
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Detailed Description

Brain-gut axis plays a crucial role in the pathogenesis of Crohn's disease (CD); however, CD neurophenotype and its impact on intestinal disease progression remain unclear. We aimed to develop a novel multimodal neuroimaging-based model to characterize the neurophenotype of CD patients and assess its ability for predicting disease progression, using multiomics data to interpret the model. This study enrolled CD patients who underwent baseline testing (including neuroimaging, psychological scales, MR enterography, and ileocolonoscopy) and faecal/blood samples collection. The neurophenotypes of patients were characterized using a neuroimaging-based model. The predictive ability of neurophenotype model for disease progression was evaluated using Cox regression analysis. Multiomics data (including faecal microbiome, faecal/blood metabolomics, intestinal permeability, blood-brain-barrier permeability, and blood neurotransmitter levels) were used to elucidate how neurophenotypes reflect brain-gut interactions.

Study Timeline

• Study Start: 2021-05-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-05
• Last Update Submitted: 2024-06-05
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The area under the ROC curve (AUC) to assess the performance of diagnostic model	6 months	After baseline brain MRI scanning, patients were followed up.

Trial Locations

Locations (1)

XploreMET v3.0 system; 🇨🇳 Shanghai, China