Using Fenofibrate to treat Ulcerative Colitis
Clinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative Colitis
This study is testing if Fenofibrate can help people with mild to moderate Ulcerative Colitis feel better by reducing inflammation in the colon.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT05753267 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Fenofibrate, a PPARα agonist, on patients with mild to moderate Ulcerative Colitis (UC). The study aims to explore the anti-inflammatory properties of Fenofibrate, which may help modulate lipid metabolism and reduce inflammation in the colon. Participants will receive either Fenofibrate or Mesalamine to assess the efficacy of these treatments in managing UC symptoms. The trial includes both Phase 2 and Phase 3 evaluations to ensure comprehensive assessment of safety and effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of mild to moderate Ulcerative Colitis.
Not a fit: Patients with severe Ulcerative Colitis or other inflammatory bowel diseases, as well as those with significant liver or kidney issues, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from Ulcerative Colitis.
How similar studies have performed: While the use of PPARα agonists like Fenofibrate in inflammatory bowel diseases is promising, this specific application in Ulcerative Colitis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Both males and females will be included * Negative pregnancy test and effective contraception. * Mild and moderate UC patients diagnosed and confirmed by an endoscope Exclusion Criteria: * Breastfeeding * Significant liver and kidney function abnormalities * Colorectal cancer patients * Other inflammatory bowel diseases (CD). * 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 Fenofibrate
Where this trial is running
Tanta
- Tanta Unuversity — Tanta, 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.