Inflammatory Bowel Diseases
Conditions
Brief summary
Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of 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.
Detailed description
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however the exact underlying mechanisms of UC remain poorly understood. UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors. PPARα has been proposed as a key lipid metabolism modulator and regulator of inflammation. There are three isotypes of PPAR (α, β and ȣ) which have distinct but overlapping functions. Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment for 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 (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management. It is the first line therapy for mild to moderate UC and it is considered the cornerstone in the management of UC
Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of hypercholesterolemia and hypertriglyceridemia.
Sponsors
Tanta University
Hend El-Said Abo Mansour, Faculty of Pharmacy, Menoufia University
Monir Hussein Bahgat, Faculty of Medicine, Mansura 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 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
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 | HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO) | 6 months | The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO) |
Countries
Egypt
Outcome results
None listed