Clinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
Overview
- Phase
- Phase 2
- Intervention
- Metformin
- Conditions
- Inflammatory Bowel Diseases
- Sponsor
- Tanta University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The primary endpoint is the change in partial mayo score index
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of UC remain poorly understood.UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.
Investigators
Mostafa Bahaa
Teaching Assistant
Tanta University
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •Both males and females will be included
- •Negative pregnancy test and effective contraception
Exclusion Criteria
- •Breast feeding
- •Significant liver and kidney function abnormalities
- •Diabetic patients
- •Colorectal cancer patients
- •Patients with severe UC
- •Patients taking rectal or systemic steroids
- •Patients taking immunosuppressives or biological therapies
- •Addiction to alcohol and / or drugs
- •Known allergy to the studied medications
Arms & Interventions
metformin group
this group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months
Intervention: Metformin
Outcomes
Primary Outcomes
The primary endpoint is the change in partial mayo score index
Time Frame: 6 months
The Partial Mayo Score index is a non-invasive clinical scale used to assess the severity of ulcerative colitis. It is a composite of sub scores from three categories, including stool frequency, rectal bleeding, and physician's global assessment, with a total score ranging from 0-9
Secondary Outcomes
- The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha(6 months)