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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2024-12-20

Brief Summary

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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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Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double-blind

Study Groups

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Control Group

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

Group Type ACTIVE_COMPARATOR

Mesalamine

Intervention Type DRUG

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

Fenofibrate group

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

Group Type ACTIVE_COMPARATOR

Mesalamine

Intervention Type DRUG

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

Fenofibrate

Intervention Type DRUG

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

Interventions

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Mesalamine

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

Intervention Type DRUG

Fenofibrate

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No