Evaluating atorvastatin for treating ulcerative colitis
Repurposing Atorvastatin in Patients With Ulcerative Colitis Treated With Mesalamine by Modulation of mTOR/NLRP3 Pathway.
PHASE2 · Tanta University · NCT05567068
This study is testing if adding atorvastatin to the usual treatment can help adults with ulcerative colitis feel better and improve their health.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tanta University (other) |
| Locations | 1 site (Mansoura) |
| Trial ID | NCT05567068 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of atorvastatin, a statin known for its anti-inflammatory and immunomodulatory effects, in patients with ulcerative colitis. Participants will receive atorvastatin at a dosage of 80mg alongside mesalamine, a standard treatment for this condition. The study aims to assess whether atorvastatin can improve symptoms and overall health in individuals suffering from inflammatory bowel diseases. The trial is designed for adults aged 18 and older, ensuring a diverse participant pool.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with ulcerative colitis who meet the inclusion criteria.
Not a fit: Patients with severe ulcerative colitis, those taking immunosuppressives or biological therapies, or individuals with significant liver and kidney function abnormalities 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 the use of statins for inflammatory conditions is being explored, this specific approach with atorvastatin 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. Exclusion Criteria: * Breastfeeding * 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
Where this trial is running
Mansoura
- Faculty of Medicine, Mansoura University — Mansoura, 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.
Conditions: Inflammatory Bowel Diseases