Fenofibrate in Ulcerative Colitis

Tanta University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Mesalamine; Drug: Fenofibrate 160mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05753267

R.23

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Mesalamine group will receive 1 g mesalamine three times daily for 6 months

Treatment:

Drug: Mesalamine

Fenofibrate group

Active Comparator group

Description:

Fenofibrate group will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months

Treatment:

Drug: Fenofibrate 160mg