Clinical trial NCT05753267: Fenofibrate in Ulcerative Colitis
Official title: Clinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Hend El-Said Abo Mansour, Faculty of Pharmacy, Menoufia University
name: Monir Hussein Bahgat, Faculty of Medicine, Mansura University
First posted: 2023-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL)
timeFrame: 6 months
Secondary outcomes:
measure: The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO)
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta Unuversity
Study officials:
References: