Neurophenotype Predicts CD Disease Progression

Sun Yat-sen University

Status: Enrolling

Conditions: Multi-omics; Radiomics

Treatments: Diagnostic Test: Logistic regression (LR) prediction models

Study type: Observational

Funder types: Other

Identifiers

NCT06452550

82070680

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

Crohn's disease patients with no-to-mild inflammation

Description:

On MR enterography, the Magnetic Resonance Index of Activity (MaRIA) and Magnetic Resonance Enterography Global Score (MEGS) were used to characterize intestinal inflammation by assessing intramural and extramural lesions in both the small and large intestines. In ileocolonoscopy, the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) was used to quantify mucosal or luminal lesions from the terminal ileum to the colorectum. Both modalities were used to classify patients with no-to-mild or moderate-to-severe inflammation. We defined patients as having moderate-to-severe inflammation when at least two of the following criteria were met: (1) MaRIA≥11; (2) MEGS≥ 10 for the small bowel or MEGS≥12 for the colon; or (3) SES-CD≥11. Otherwise, patients were categorized as having no-to-mild inflammation.

Treatment:

Diagnostic Test: Logistic regression (LR) prediction models

Crohn's disease patients with moderate-to-severe inflammation

Description:

On MR enterography, the Magnetic Resonance Index of Activity (MaRIA) and Magnetic Resonance Enterography Global Score (MEGS) were used to characterize intestinal inflammation by assessing intramural and extramural lesions in both the small and large intestines. In ileocolonoscopy, the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) was used to quantify mucosal or luminal lesions from the terminal ileum to the colorectum. Both modalities were used to classify patients with no-to-mild or moderate-to-severe inflammation. We defined patients as having moderate-to-severe inflammation when at least two of the following criteria were met: (1) MaRIA≥11; (2) MEGS≥ 10 for the small bowel or MEGS≥12 for the colon; or (3) SES-CD≥11. Otherwise, patients were categorized as having no-to-mild inflammation.

Treatment:

Diagnostic Test: Logistic regression (LR) prediction models