Fenofibrate in Ulcerative Colitis

Phase

2/3

Condition

Gastrointestinal Diseases And Disorders

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Fenofibrate 160mg

Mesalamine

Clinical Study ID

NCT05753267

R.23

Ages 18-75
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Fenofibrate 160mg

2/3

February 28, 2023

June 20, 2026

Study 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

Connect with a study center

Tanta Unuversity
Tanta, 31527
Egypt
Active - Recruiting

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