Fenofibrate in Ulcerative Colitis

Phase 2

Recruiting

• Conditions: Inflammatory Bowel Diseases
• Interventions: Drug: Mesalamine; Drug: Fenofibrate 160mg

• Registration Number: NCT05753267
• Lead Sponsor: Tanta University

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

Study Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-02-22
• Study Start: 2023-02-28
• Study First Posted: 2023-03-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-02-20
• Study Completion: 2026-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO)	6 months	The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO)

Trial Locations

Locations (1)

Tanta Unuversity; 🇪🇬 Tanta, Egypt