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 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT04750135
Eligibility Criteria:
Inclusion Criteria:
1. Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
2. Adults (males and/or females) with age range from 18 to 65 years old.
3. Patients on treatment with 5-aminosalisylic acid (5-ASA)
Exclusion Criteria:
1. Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
2. Treatment with systemic or rectal steroids.
3. Treatment with immunosuppressants.
4. Previously failed treatment with a sulphasalazine.
5. Known hypersensitivity to any of study drugs.
6. Hepatic and renal dysfunction.
7. Pregnancy and lactation.
8. History of colorectal carcinoma.
9. History of complete or partial colectomy.
10. Current or previous treatment with metformin for females with polycystic ovarian syndrome.
11. Patients with diabetes mellitus
12. Patients with history of lactic acidosis
13. Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency
14. Positive stool culture for enteric pathogens, positive stool ova and parasite exam.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04750135
Study Brief:
Protocol Section:
NCT04750135