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

Primary Purpose

Inflammatory Bowel Diseases

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Mesalamine

Fenofibrate

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Faculty of Medicine, Menoufia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Control Group

Fenofibrate group

Arm Description

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

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

Outcomes

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).

• 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.

The secondary endpoint is estimated by changes in serum biomarkers such as adenosine monophosphate activated protein kinase

Full Information

NCT ID

NCT05781698

First Posted

March 11, 2023

Last Updated

April 9, 2023

Sponsor

Tanta University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05781698

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 20, 2023 (Actual)

Primary Completion Date

March 20, 2024 (Anticipated)

Study Completion Date

June 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

double-blind

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Fenofibrate group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Mesalamine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Fenofibrate

Intervention Description

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

Primary Outcome Measure Information:

Title

• 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).

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

The secondary endpoint is estimated by changes in serum biomarkers.

Description

The secondary endpoint is estimated by changes in serum biomarkers such as adenosine monophosphate activated protein kinase

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mostafa M Bahaa, PhD

Phone

0201025538337

mbahaa@horus.edu.eg

Facility Information:

Facility Name

Faculty of Medicine, Menoufia University

City

Tanta

State/Province

Shebeen El-Kom

ZIP/Postal Code

32511

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manal A Hamouda, PhD

Phone

0201067009096

manal.hamouda@phrm.menofia.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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