Inflammatory Bowel Diseases
Conditions
Brief summary
Fibrates, specific pharmacological agonists of PPARα, have been widely used to treat hypercholesterolemia and hypertriglyceridemia. Apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of NF-kappa B signaling and pro-inflammatory cytokine production. 4 Fenofibrate, an important peroxisome proliferator-activated receptor-a (PPAR- α) agonist, is widely used in clinical as a triglyceride (TG)-lowering agent
Interventions
DRUGMesalamine
mesalamine is the cornerstone used for the treatment of mild to moderate ulcerative colitis
DRUGFenofibrate
Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment for hypercholesterolemia and hypertriglyceridemia
Sponsors
Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Age ≥ 18 years Both male and female will be included Negative pregnancy test and effective contraception. Mild and moderate UC patients diagnosed and confirmed by endoscope
Exclusion criteria
Breast feeding 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL). | 6 months | • The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary endpoint is estimated by changes in serum biomarkers. | 6 months | The secondary endpoint is estimated by changes in serum biomarkers such as adenosine monophosphate activated protein kinase |
Countries
Egypt
Outcome results
None listed