Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

Phase 2

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Drug: Metformin

• Registration Number: NCT05553704
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Study Start: 2022-11-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-05
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin group	Metformin	this group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the change in partial mayo score index	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 Outcome Measures

Name	Time	Method
The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha	6 months	The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha

Trial Locations

Locations (1)

Faculty of Medicine, Mansoura University; 🇪🇬 Mansoura, Egypt