Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis

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

Official Title
-----------------
Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis

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

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


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

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>The control group ( Mesalamine group, n =35 ) will receive 1 g mesalamine three times daily for 6 months | Drug: Mesalamine<br>* mesalamine is the cornerstone used for the treatment of mild to moderate ulcerative colitis<br>|
| Active Comparator: Fenofibrate group<br>Patients will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months | Drug: Mesalamine<br>* mesalamine is the cornerstone used for the treatment of mild to moderate ulcerative colitis<br>Drug: Fenofibrate<br>* Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment for 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). Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). | • The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoint is estimated by changes in serum biomarkers. | The secondary endpoint is estimated by changes in serum biomarkers such as adenosine monophosphate activated protein kinase | 6 months |