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Fenofibrate in Ulcerative Colitis

Primary Purpose

Inflammatory Bowel Diseases

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Mesalamine
Fenofibrate 160mg
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tanta UnuversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control Group

Fenofibrate group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
February 22, 2023
Last Updated
March 11, 2023
Sponsor
Tanta University
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05753267
Brief Title
Fenofibrate in Ulcerative Colitis
Official Title
Clinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
February 20, 2025 (Anticipated)
Study Completion Date
June 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Mesalamine group will receive 1 g mesalamine three times daily for 6 months
Arm Title
Fenofibrate group
Arm Type
Active Comparator
Arm Description
Fenofibrate group will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months
Intervention Type
Drug
Intervention Name(s)
Mesalamine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Fenofibrate 160mg
Intervention Description
Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of hypercholesterolemia and hypertriglyceridemia.
Primary Outcome Measure Information:
Title
The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL)
Description
HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO)
Description
The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Bahaa, PhD
Phone
0201025538337
Email
mbahaa@horus.edu.eg
Facility Information:
Facility Name
Tanta Unuversity
City
Tanta
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman I Elberri, PhD
Phone
0201003592593
Email
mbahaa@horus.edu.eg
First Name & Middle Initial & Last Name & Degree
Mostafa M Bahaa, PhD

12. IPD Sharing Statement

Learn more about this trial

Fenofibrate in Ulcerative Colitis

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