Empagliflozin for people with mild to moderate ulcerative colitis

Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis

This will see if adding empagliflozin to usual medications helps people with mild to moderate ulcerative colitis.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Tanta University (Academic / other)
• Locations: 1 site (Tanta)
• Trial ID: NCT05610956 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled, parallel early-phase study enrolling 60 patients with mild to moderate ulcerative colitis at Tanta University Hospital. Participants are randomized 1:1 to receive standard therapy (corticosteroids, immunosuppressants, and aminosalicylates) with or without empagliflozin (0.4–0.5 mg/kg/day, up to 25 mg/day) for four months. Patients undergo baseline and 4-month assessments including colonoscopy with biopsies, routine labs, fecal calprotectin, TNF-α, and AMPK measurements. The trial uses clinical improvement by the Montreal classification and laboratory markers to compare safety and potential efficacy between groups.

Who should consider this trial

Good fit: Adults with mild to moderate ulcerative colitis confirmed by endoscopy and biopsy, who are not on dialysis, do not have severe renal impairment, chronic urinary or genital infections, or hypersensitivity to empagliflozin, would be eligible.

Not a fit: People with severe ulcerative colitis, other inflammatory bowel diseases (like Crohn's), severe renal impairment or on dialysis, chronic urinary/genital infections, or empagliflozin allergy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding empagliflozin could reduce inflammation and symptoms and improve disease control for people with mild to moderate ulcerative colitis.

How similar studies have performed: Using SGLT2 inhibitors like empagliflozin for ulcerative colitis is largely novel with limited prior clinical data, so this represents an early, exploratory approach rather than a well-established treatment.

Eligibility criteria

Inclusion Criteria:

•Patients with mild to moderate UC are diagnosed by history, clinical signs according to the Montreal classification of severity of ulcerative colitis and( Endoscopy, and biopsy) to establish the chronicity of inflammation and to exclude other causes of colitis.

Exclusion Criteria:

* Other inflammatory bowel diseases (CD).
* History of serious hypersensitivity to empagliflozin or any component of the formulation.
* Patients on dialysis.
* Severe renal impairment (eGFR \<20 ml/minute/1.73m2) .
* Chronic urinary tract infection.
* Chronic genital infection.

Where this trial is running

Tanta

• Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital. — Tanta, Egypt (Recruiting)

Study contacts

• Study coordinator: youmna H eldeeb, phD

Conditions Ulcerative Colitis