Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis

April 9, 2024 updated by: Mostafa Bahaa, Tanta University
Fibrates, specific pharmacological agonists of PPARα, have been widely used to treat 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Shebeen El-Kom
      • Tanta, Shebeen El-Kom, Egypt, 32511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age ≥ 18 years Both male and female will be included Negative pregnancy test and effective contraception. Mild and moderate UC patients diagnosed and confirmed by endoscope

Exclusion Criteria:

Breast feeding 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
The control group ( Mesalamine group, n =35 ) will receive 1 g mesalamine three times daily for 6 months
Drug: Mesalamine
mesalamine is the cornerstone used for the treatment of mild to moderate ulcerative colitis
Active Comparator: Fenofibrate group
Patients will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months
Drug: Mesalamine
mesalamine is the cornerstone used for the treatment of mild to moderate ulcerative colitis
Drug: Fenofibrate
Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment for hypercholesterolemia and hypertriglyceridemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL). Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Time Frame: 6 months
• The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary endpoint is estimated by changes in serum biomarkers.
Time Frame: 6 months
The secondary endpoint is estimated by changes in serum biomarkers such as adenosine monophosphate activated protein kinase
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Collaborators

Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta University
Fedaa Abd El-monem Kamal El-deen Kotkata Faculty of Pharmacy, Tanta University
Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Estimated)

October 20, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

March 11, 2023

First Submitted That Met QC Criteria

March 11, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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