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

Phase 2

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Drug: Mesalamine; Drug: Fenofibrate

• Registration Number: NCT05781698
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-11
• Study First Submitted QC: 2023-03-11
• Study Start: 2023-03-20
• Study First Posted: 2023-03-23
• Primary Completion: 2024-10-20
• Study Completion: 2024-12-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fenofibrate group	Fenofibrate	Patients will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months
Control Group	Mesalamine	The control group ( Mesalamine group, n =35 ) will receive 1 g mesalamine three times daily for 6 months
Fenofibrate group	Mesalamine	Patients will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months

Primary Outcome Measures

Name	Time	Method
• The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL).	6 months	• The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL).

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint is estimated by changes in serum biomarkers.	6 months	The secondary endpoint is estimated by changes in serum biomarkers such as adenosine monophosphate activated protein kinase

Trial Locations

Locations (1)

Faculty of Medicine, Menoufia University; 🇪🇬 Tanta, Shebeen El-Kom, Egypt