Using Dapagliflozin to Treat Inflammatory Bowel Disease
Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease
This study is testing if the diabetes medication Dapagliflozin can help people with mild to moderate ulcerative colitis feel better by reducing inflammation.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Months to 60 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Al Mansurah) |
| Trial ID | NCT05986136 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Dapagliflozin, a medication known for its role in managing diabetes, on patients with inflammatory bowel diseases (IBD), specifically mild to moderate ulcerative colitis. The study aims to activate autophagy and suppress apoptosis to reduce inflammation and improve symptoms associated with IBD. Participants will receive Dapagliflozin alongside Mesalamine, and their responses will be monitored to assess the treatment's efficacy. The trial is designed to gather data from both Phase 2 and Phase 3 to ensure comprehensive evaluation of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with mild to moderate ulcerative colitis confirmed by endoscopy.
Not a fit: Patients with severe ulcerative colitis, colorectal cancer, or those on certain immunosuppressive therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms and improve the quality of life for patients suffering from inflammatory bowel diseases.
How similar studies have performed: While the specific approach of using Dapagliflozin for IBD is novel, similar studies targeting inflammation through metabolic pathways have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Both male and female will be * Mild and moderate UC patients diagnosed and confirmed by endoscope Exclusion Criteria: * Breast feeding * Significant liver and kidney function abnormalities * Colorectal cancer patients * Patients with severe UC * Patients taking rectal or systemic steroids * Patients taking immunosuppressives or biological therapies * Addiction to alcohol and / or drugs * Known allergy to the dapagliflozin
Where this trial is running
Al Mansurah
- Faculty of Medicine, Mansoura University — Al Mansurah, Egypt (Recruiting)
Study contacts
- Study coordinator: Mostafa Bahaa, PhD
- Email: mbahaa@horus.edu.eg
- Phone: 0201025538337
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.