Fenofibrate in Ulcerative Colitis

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05753267

Collaborator

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

Enrollment

Location

Arms

27.7

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Drug: Mesalamine Drug: Fenofibrate 160mg	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

double-blind

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 28, 2023

Anticipated Primary Completion Date :

Feb 20, 2025

Anticipated Study Completion Date :

Jun 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group Mesalamine group will receive 1 g mesalamine three times daily for 6 months	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
Active Comparator: Fenofibrate group Fenofibrate group will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months	Drug: Fenofibrate 160mg Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of hypercholesterolemia and hypertriglyceridemia.

Arm

Intervention/Treatment

Active Comparator: Control Group

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

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

Active Comparator: Fenofibrate group

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

Drug: Fenofibrate 160mg

Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of hypercholesterolemia and hypertriglyceridemia.

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta Unuversity	Tanta		Egypt	31527

Sponsors and Collaborators

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