Using brain imaging to predict Crohn's disease progression
Multimodal MRI-based Neurophenotype Reflecting Brain-gut Interactions to Predict Intestinal Disease Progression in Patients With Crohn's Disease
This study is trying to see if brain scans and other tests can help predict how Crohn's disease will progress in patients over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06452550 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a multimodal neuroimaging-based model to characterize the neurophenotype of patients with Crohn's disease (CD) and assess its predictive ability for disease progression. Participants will undergo various assessments, including neuroimaging, psychological evaluations, and collection of blood and fecal samples. The study will follow patients for at least six months to evaluate the relationship between their neurophenotype and intestinal outcomes. By integrating multiomics data, the study seeks to elucidate the brain-gut interactions that may influence disease progression.
Who should consider this trial
Good fit: Ideal candidates for this study are Crohn's disease patients aged 18-45 who can complete the required multimodal assessments.
Not a fit: Patients with recent antibiotic use, certain neurological conditions, or contraindications for MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel method for predicting disease progression in Crohn's disease patients, potentially leading to more personalized treatment strategies.
How similar studies have performed: While the integration of neuroimaging and multiomics data in predicting disease progression is innovative, similar approaches have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- XploreMET v3.0 system — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xuehua Li — Sun Yat-sen University First Affiliated Hospital Department of Radiology
- Study coordinator: Xuehua Li
- Email: lxueh@mail.sysu.edu.cn
- Phone: 13580364103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.