Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

April 5, 2025 updated by: Mostafa Bahaa, Tanta University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35511
        • Faculty of medicine, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
this group will take mesalamine 1 gm three times daily for 6 months
Active Comparator: metformin group
this group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months
Drug: Metformin
metformin group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha
Time Frame: 6 months
The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 5, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3422 (FDA OOPD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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