Fenofibrate in Ulcerative Colitis

Study Overview
=================
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

Official Title
-----------------
Clinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative Colitis

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Drug: Mesalamine
* Drug: Fenofibrate 160mg


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Mesalamine group will receive 1 g mesalamine three times daily for 6 months | Drug: Mesalamine<br>* 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<br>|
| Active Comparator: Fenofibrate group<br>Fenofibrate group will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months | Drug: Fenofibrate 160mg<br>* Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of hypercholesterolemia and hypertriglyceridemia.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL) | HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO) | The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO) | 6 months |