Ulcerative Colitis
Conditions
Interventions
Control group:Vedolizumab
Test group:Vedolizumab+Ursodeoxycholic Acid (10-15mg/kg)
Sponsors
General Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 years or older; 2. The patient was clearly diagnosed as an IBD patient through medical history, laboratory tests, imaging data, endoscopy, etc; 3. VDZ treatment should be used for at least 4 times or more during the treatment period; 4. After 14/52 weeks of VDZ treatment, the Mayo score decreased significantly, but endoscopic improvement was not achieved; 5. Voluntarily join this study, sign the informed consent form and be able to abide by the visits and related procedures stipulated in the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of allergy to ursodeoxycholic acid capsules or those with contraindications such as biliary obstruction; 2. The clinical and follow-up data were incomplete, or the treatment was discontinued within 14 weeks of VDZ treatment due to compliance issues; 3. Concurrent active infections (such as toxic megacolon, tuberculosis, bacteremia, etc.) or tumors and other non-infectious diseases; 4. Patients with critical conditions who require prompt intervention through surgery or other means; 5. There exists any situation that the researcher believes may expose the subjects to an unacceptable risk of complications, interfere with the evaluation of the investigational drug, or cause confounding in the interpretation of the subjects' safety or the research results; 6. Severe dysfunction of important organs such as the heart, liver and kidneys; 7. Suffer from mental illness; 8. Pregnancy or lactation; 9. Patients who are not suitable for colonoscopy; 10. Other situations that cannot be included as discovered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improved Mayo Score;Erythrocyte sedimentation rate;C-reactive protein;Fecal Calprotectin; | — |
Countries
China
Contacts
Public ContactHailong Cao
Tianjin Medical University General Hospital
Outcome results
None listed