Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

Phase 2

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: Empagliflozin 10 MG; Drug: Placebo

• Registration Number: NCT05058417
• Lead Sponsor: Sadat City University

Brief Summary

This is a randomized, controlled study evaluating empagliflozin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of empagliflozin 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

• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-27
• Study Start: 2021-10-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• 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.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin group	Empagliflozin 10 MG	participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy
Placebo	Placebo	participants will receive placebo for 8 consecutive weeks in addition to the standard therapy

Primary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Pharmacy; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt