Clinical trial

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

Name

3422

Description

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.

Trial arms

Trial start

2022-11-01

Estimated PCD

2025-11-01

Trial end

2025-12-20

Status

Recruiting

Phase

Early phase I

Treatment

Metformin

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

Arms:

metformin group

Size

Primary endpoint

The primary endpoint is the change in partial mayo score index

6 months

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-12-28

1 organization

1 drug

1 indication

Organization

Tanta University

Drug

Metformin

Indication

Inflammatory Bowel Disease