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OpenTrials
Completed

NCT Number: NCT05553704

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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Mansoura University

Al Mansurah, 35511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

  • Maha Mohamed Maher Internal Medicine Department Mansoura University
  • Mounir Hussein Bahgat Internal Medicine Department Mansoura University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2022
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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