RecruitingPhase 2Phase 3NCT05753267

Fenofibrate in Ulcerative Colitis

Clinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative Colitis


Sponsor

Tanta University

Enrollment

60 participants

Start Date

Feb 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of 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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • Age ≥ 18 years
  • Both males and females will be included
  • Negative pregnancy test and effective contraception.
  • Mild and moderate UC patients diagnosed and confirmed by an endoscope

Exclusion Criteria9

  • Breastfeeding
  • 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

Interventions

DRUGMesalamine

Mesalamine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management. It is the first line therapy for mild to moderate UC and it is considered the cornerstone in the management of UC

DRUGFenofibrate 160mg

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


Locations(1)

Tanta Unuversity

Tanta, Egypt

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NCT05753267


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