Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04750135

Enrollment

Registered

2021-02-11

Start date

2021-02-07

Completion date

2021-06-01

Last updated

2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Ulcerative Colitis

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.

Interventions

DRUGmetformin 500 mg TID Oral Tablet

biguanides derivatives

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Countries

Egypt

Contacts

Primary ContactDoaa Hamed, PhD

Abdelaziz.h.doaa@gmail.com+202 23642494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026