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OpenTrials
Completed

NCT Number: NCT05781698

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

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

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Menoufia University

Tanta, Shebeen El-Kom, 32511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesalamine

Drug

mesalamine is the cornerstone used for the treatment of mild to moderate ulcerative colitis

fenofibrate

Drug

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

Primary outcomes

  1. • The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL).

    Time frame: 6 months

    • The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL).

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

  • Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 23, 2023
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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