Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis

• Status: Not yet recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Brief Summary:

This is a randomized, controlled study evaluating metformin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of metformin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Hepatology & Tropical Medicine Research Institute
• Treatments: Metformin

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.