Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

Inflammatory Bowel Diseases Clinical Trial

Official title:

Clinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553704
• Other study ID #: 3422
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2022
• Est. completion date: December 20, 2025

Study information

• Verified date: December 2023
• Source: Tanta University
• Contact: Mostafa Bahaa
• Phone: 0201025538337
• Email: mostafabahaamnf[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 20, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases

Intervention

Drug:
• Metformin
metformin group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Mansoura University	Mansoura

Sponsors (5)

Lead Sponsor	Collaborator
Tanta University	Maha Mohamed Maher Internal Medicine Department Mansoura University, Mounir Hussein Bahgat Internal Medicine Department Mansoura University, Sahar Kamal Hegazi clinical pharmacy department, Tanta University, Sahar Mohamed El-Haggar clinical pharmacy department, Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the change in partial mayo score index	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	6 months
Secondary	The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha	The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha	6 months