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Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

T

Tanta University

Status and phase

Enrolling
Phase 2

Conditions

Inflammatory Bowel Diseases

Treatments

Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT05553704
3422 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Mostafa Bahaa

Data sourced from clinicaltrials.gov

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