Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis

Phase 2

• Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases
• Interventions: Drug: Placebo; Drug: metformin 500 mg TID Oral Tablet

• Registration Number: NCT04750135
• Lead Sponsor: National Hepatology & Tropical Medicine Research Institute

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 treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-02-07
• Study First Submitted: 2021-02-07
• Study First Submitted QC: 2021-02-07
• Last Update Submitted: 2021-02-07
• Study First Posted: 2021-02-11
• Last Update Posted: 2021-02-11
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
2. Adults (males and/or females) with age range from 18 to 65 years old.
3. Patients on treatment with 5-aminosalisylic acid (5-ASA)

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Exclusion Criteria

1. Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
2. Treatment with systemic or rectal steroids.
3. Treatment with immunosuppressants.
4. Previously failed treatment with a sulphasalazine.
5. Known hypersensitivity to any of study drugs.
6. Hepatic and renal dysfunction.
7. Pregnancy and lactation.
8. History of colorectal carcinoma.
9. History of complete or partial colectomy.
10. Current or previous treatment with metformin for females with polycystic ovarian syndrome.
11. Patients with diabetes mellitus
12. Patients with history of lactic acidosis
13. Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency
14. Positive stool culture for enteric pathogens, positive stool ova and parasite exam.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	participants will receive placebo for 8 consecutive weeks in addition to the standard therapy
Metformin group	metformin 500 mg TID Oral Tablet	participants will receive 500 mg Metformin TID for 8 consecutive weeks in addition to the standard therapy

Primary Outcome Measures

Name	Time	Method
Difference between the two groups in the expression of colonic (NF)-κB proteins.	8 weeks

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, الغربية, Egypt