Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis

National Hepatology & Tropical Medicine Research Institute

Status and phase: Unknown; Phase 2

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases

Treatments: Drug: metformin 500 mg TID Oral Tablet; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04750135

21-2019

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

participants will receive placebo for 8 consecutive weeks in addition to the standard therapy

Treatment:

Drug: Placebo

Metformin group

Experimental group

Description:

participants will receive 500 mg Metformin TID for 8 consecutive weeks in addition to the standard therapy

Treatment:

Drug: metformin 500 mg TID Oral Tablet