Inflammatory bowel diseases
Conditions
Interventions
Retrospective cohort (divided into a training set (140 cases) and a validation set (60 cases) in a 7:3 ratio):None
Prospective cohort:None
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Retrospectively include 200 IBD patients (including UC and CD subtypes) who received CFR treatment before July 2025. 2. Prospectively recruit 100 IBD patients who have not previously received CFR treatment (recruitment to be completed between July 2025 and June 2028): (1) Diagnosed with IBD according to the 2020 Chinese Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease; (2) Aged 18–65 years; (3) Voluntarily accept Changfu Formula (CFR) treatment and provide informed consent.
Exclusion criteria
Exclusion criteria: Prospective cohort 1. Presence of severe intestinal complications (such as intestinal perforation or severe bleeding); 2. Presence of other autoimmune diseases; 3. Severe abnormalities in liver and kidney function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Response/Remission in IBD (MAYO score reduction >=30% and at least 1 point for UC; CDAI score reduction >=70 points for CD);Time to Disease Relapse; | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance Metrics of Predictive Models (Accuracy, AUC, Calibration Curve, Decision Curve Analysis);Syndrome Data (TCM Pattern Differentiation and Corresponding Syndrome Scoring Scale);Macroscopic Clinical Indicators (Number of Bowel Movements, Hemorrhage Severity, Abdominal Pain VAS Score);Imaging Features (Endoscopic Mucosal Lesion Scoring, Abdominal CT/MRI Findings of Intestinal Inflammation);Multidimensional Omics Data (Cell Subtyping, Metabolomics, Transcriptomics, Proteomics, Microbiomics); | — |
Countries
China
Contacts
Public ContactChen Ning
Peking University People's Hospital
Outcome results
None listed