Status:
UNKNOWN
Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis
Lead Sponsor:
National Hepatology & Tropical Medicine Research Institute
Conditions:
Ulcerative Colitis
Inflammatory Bowel Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Brief Summary: This is a randomized, controlled study evaluating metformin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of metformin in the ...
Eligibility Criteria
Inclusion
- Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
- Adults (males and/or females) with age range from 18 to 65 years old.
- Patients on treatment with 5-aminosalisylic acid (5-ASA)
Exclusion
- Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
- Treatment with systemic or rectal steroids.
- Treatment with immunosuppressants.
- Previously failed treatment with a sulphasalazine.
- Known hypersensitivity to any of study drugs.
- Hepatic and renal dysfunction.
- Pregnancy and lactation.
- History of colorectal carcinoma.
- History of complete or partial colectomy.
- Current or previous treatment with metformin for females with polycystic ovarian syndrome.
- Patients with diabetes mellitus
- Patients with history of lactic acidosis
- Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency
- Positive stool culture for enteric pathogens, positive stool ova and parasite exam.
Key Trial Info
Start Date :
February 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04750135
Start Date
February 7 2021
End Date
June 1 2021
Last Update
February 11 2021
Active Locations (1)
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1
Tanta University Hospitals
Tanta, Gharbia Governorate, Egypt