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

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05781698

Collaborator

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

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Drug: Mesalamine Drug: Fenofibrate	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

double-blind

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 20, 2023

Anticipated Primary Completion Date :

Mar 20, 2024

Anticipated Study Completion Date :

Jun 20, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

• 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). [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Menoufia University	Tanta	Shebeen El-Kom	Egypt	32511

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mostafa Bahaa, Teaching Assistant, Tanta University

ClinicalTrials.gov Identifier:

NCT05781698

Other Study ID Numbers:

1-2023

First Posted:

Mar 23, 2023

Last Update Posted:

Mar 23, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Inflammatory Bowel Diseases

Mesalamine

Fenofibrate

Study Results

No Results Posted as of Mar 23, 2023