A Multicentered Prospective Cohort Study of Chinese IBD Patients

Status Enrolling by invitation

Clinical Trial Summary

Inflammatory bowel disease(IBD), including ulcerative colitis (UC) and Crohn's disease (CD), is characterized by chronic and recurrent nonspecific intestinal inflammation with high disability rate. During the past few decades, the prevalence of IBD is increasing, especially in developing countries, which brings great burden to patients themselves and medical insurance. Currently, biological medications such as TNFα inhibitors (infliximab, adalimumab, etc.), integrin receptor antagonist (vedolizumab) and interleukin 12/interleukin 23 inhibitor (ustekinumab) are commonly used in IBD treatment as well as traditional drugs such as glucocorticoid, immunosupressive agents and 5-Aminosalicylic Acid, and surgury. However, health-econimic analysis is lacking in Chinese IBD patients and more research is needed for making treatment choice. Meanwhile, the etiology, disease progression and prognosis prediction has not totally been clarified. The efficacy prediction model of vedolizumab and infliximab has been analyzed, whose prediction markers include level of albumin, smoking, surgery history, fistula, etc. However, no model has included predictors concerning disease pathway or pharmacological pathway in patients accepting different therapy. So a model to predict IBD progression and prognosis concerning pharmacological pathway is going to be explored.

Clinical Trial Description

The research is aimed at exploring the mode of IBD progression and predicting prognosis of different IBD patients so that treatment choice could be made to get better efficacy and decrease economic burden of patients and medical insurance. So blood and stool samples before and after treatment are collected to detect changes in gut microbiota and blood proteomics markers and explore the prediction model. Also, inflammatory bowel disease questionnaire (IBDQ) and EQ5D3L will be collected and cost-utility analysis will be conducted. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05386290
Study type	Observational
Source	Peking Union Medical College Hospital
Contact
Status	Enrolling by invitation
Phase
Start date	July 9, 2020
Completion date	December 2023

View Details

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