Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05553704

Enrollment

Registered

2022-09-23

Start date

2022-11-01

Completion date

2025-03-01

Last updated

2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

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.

Interventions

DRUGMetformin

metformin group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026