Fenofibrate in Ulcerative Colitis

Inflammatory Bowel Diseases Clinical Trial

Official title:

Clinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753267
• Other study ID #: R.23
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 28, 2023
• Est. completion date: June 20, 2025

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: Mostafa Bahaa, PhD
• Phone: 0201025538337
• Email: mbahaa[@]horus.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 20, 2025
• Est. primary completion date: February 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases

Intervention

Drug:
• Mesalamine
Mesalamine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management. It is the first line therapy for mild to moderate UC and it is considered the cornerstone in the management of UC
• Fenofibrate 160mg
Fibrates, which are specific pharmacological agonists of PPARa, have been widely used in the treatment of hypercholesterolemia and hypertriglyceridemia.

Locations

Country	Name	City	State
Egypt	Tanta Unuversity	Tanta

Sponsors (5)

Lead Sponsor	Collaborator
Tanta University	Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta University, Eman Maamoun Ali El-Khateeb, Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Hend El-Said Abo Mansour, Faculty of Pharmacy, Menoufia University, Monir Hussein Bahgat, Faculty of Medicine, Mansura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL)	HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms.	6 months
Secondary	The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO)	The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO)	6 months