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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05781698
• Other study ID #: 1-2023
• Status: Recruiting
• Phase: Phase 2
• Start date: March 20, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: Mostafa M Bahaa, PhD
• Phone: 0201025538337
• Email: mbahaa[@]horus.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 20, 2024
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases

Intervention

Drug:
• Mesalamine
mesalamine is the cornerstone used for the treatment of mild to moderate ulcerative colitis
• Fenofibrate
Fibrates, which are specific pharmacological agonists of PPARa, have been widely used in the treatment for hypercholesterolemia and hypertriglyceridemia

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Menoufia University	Tanta	Shebeen El-Kom

Sponsors (4)

Lead Sponsor	Collaborator
Tanta University	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

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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).	• The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL).	6 months
Secondary	The secondary endpoint is estimated by changes in serum biomarkers.	The secondary endpoint is estimated by changes in serum biomarkers such as adenosine monophosphate activated protein kinase	6 months