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临床试验/NCT06452550
NCT06452550招募中不适用

Multimodal MRI-based Neurophenotype Reflecting Brain-gut Interactions to Predict Intestinal Disease Progression in Patients With Crohn's Disease

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
The area under the ROC curve (AUC) to assess the performance of diagnostic model

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • (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.

排除标准

  • (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.

结局指标

主要结局

The area under the ROC curve (AUC) to assess the performance of diagnostic model

时间窗: 6 months

After baseline brain MRI scanning, patients were followed up.

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xuehua Li

associate chief physician

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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