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

Tanta University

Status and phase: Enrolling; Phase 2

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Mesalamine; Drug: Fenofibrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05781698

1-2023

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Control Group

Active Comparator group

Description:

The control group ( Mesalamine group, n =35 ) will receive 1 g mesalamine three times daily for 6 months

Treatment:

Drug: Mesalamine

Fenofibrate group

Active Comparator group

Description:

Patients will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months

Treatment:

Drug: Mesalamine

Drug: Fenofibrate