Using empagliflozin to treat ulcerative colitis
Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis
This study is testing if a daily medication called empagliflozin can help people with mild to moderate ulcerative colitis feel better over 8 weeks compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sadat City University Academic / other |
| Locations | 1 site (Shibīn Al Kawm, Menoufia) |
| Trial ID | NCT05058417 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of empagliflozin, administered daily for 8 weeks, in patients with mild to moderately active ulcerative colitis. Participants will undergo a colonoscopy at the beginning and end of the study to assess disease activity using the Mayo score. The study is randomized and controlled, comparing empagliflozin to a placebo. The goal is to determine if empagliflozin can serve as an effective adjuvant therapy for this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with mild to moderate ulcerative colitis diagnosed via colonoscopy.
Not a fit: Patients with severe ulcerative colitis or those on systemic steroids or immunosuppressants may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with ulcerative colitis, potentially improving their quality of life.
How similar studies have performed: While this approach is relatively novel, similar studies have shown promise in using adjunct therapies for ulcerative colitis.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shibīn Al Kawm, Menoufia
- Faculty of Pharmacy — Shibīn Al Kawm, Menoufia, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.