Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-07

Study Completion Date

2021-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Metformin group

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

Group Type EXPERIMENTAL

metformin 500 mg TID Oral Tablet

Intervention Type DRUG

biguanides derivatives

Interventions

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metformin 500 mg TID Oral Tablet

biguanides derivatives

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Glucophage XR

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No