Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Ulcerative Colitis
- Sponsor
- National Hepatology & Tropical Medicine Research Institute
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Difference between the two groups in the expression of colonic (NF)-κB proteins.
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Doaa abdelaziz
Lecturer at pharmacy practice department, FUE, Egypt
National Hepatology & Tropical Medicine Research Institute
Eligibility Criteria
Inclusion Criteria
- •Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
- •Adults (males and/or females) with age range from 18 to 65 years old.
- •Patients on treatment with 5-aminosalisylic acid (5-ASA)
Exclusion Criteria
- •Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
- •Treatment with systemic or rectal steroids.
- •Treatment with immunosuppressants.
- •Previously failed treatment with a sulphasalazine.
- •Known hypersensitivity to any of study drugs.
- •Hepatic and renal dysfunction.
- •Pregnancy and lactation.
- •History of colorectal carcinoma.
- •History of complete or partial colectomy.
- •Current or previous treatment with metformin for females with polycystic ovarian syndrome.
Arms & Interventions
Control group
participants will receive placebo for 8 consecutive weeks in addition to the standard therapy
Intervention: Placebo
Metformin group
participants will receive 500 mg Metformin TID for 8 consecutive weeks in addition to the standard therapy
Intervention: metformin 500 mg TID Oral Tablet
Outcomes
Primary Outcomes
Difference between the two groups in the expression of colonic (NF)-κB proteins.
Time Frame: 8 weeks