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NCT05553704 | Recruiting | Inflammatory Bowel Diseases


Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
Sponsor:

Lots of University

Information provided by (Responsible Party):

Mostafa is very

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.

Condition or disease

Inflammatory Bowel Diseases

Intervention/treatment

Metformin

Phase

Phase 2

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : Double
Primary Purpose : Treatment
Official Title : Clinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
Actual Study Start Date : November 1, 2022
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : December 20, 2025
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

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

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Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

How to Participate

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Locations


Recruiting

Egypt,

Faculty of Medicine, Mansoura University

Mansoura, Egypt, 35511

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