Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT03917095
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients aged between 18 and 65
2. Patients with chronic relapsed mild to moderate active Ulcerative Colitis(left semicolon or extending colonic lesions)
3. Patients who can fully understand this study and voluntarily sign an informed consent;
4. Accept re-examination, follow-up examination and specimen retention in time
5. Suitable for colonoscopy and colonic TET;
6. A history of using Mesalazine and Compound Glutamine safely
Exclusion Criteria:
1. Anti-tumor necrosis factor or methotrexate was used within the first 8 weeks
2. Cyclosporine was used within 4 weeks
3. Antibiotics or probiotics was used within 4 weeks
4. Patients with risk of toxic megacolon, colon cancer or atypical hyperplasia found in pathology
5. History of colon surgery
6. Patients with moderate or severe renal impairment ,abnormal liver function,severe hypertension and cerebrovascular accident
7. Accompanied by other serious diseases, such as cancer or AIDS, that may hinder their enrollment or affect their survival
8. Patients with anxiety, depression, mental or legal disabilities
9. History of suspected or proven alcohol/drug abuse
10. Patients with explosive, massive bloody stools and severe illness who cannot tolerate the colonoscopy
11. Patients who are allergic to salicylic acid or aspirin
12. Patients with food allergies
13. Patients who are preparing to become pregnant during the study period
14. Patients considered by the researchers as unsuitable for enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03917095
Study Brief:
Protocol Section:
NCT03917095