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Randomized Controlled Trial
. 2024 Nov 16:18:5239-5253.
doi: 10.2147/DDDT.S490772. eCollection 2024.

Fenofibrate as an Adjunct Therapy for Ulcerative Colitis: Targeting Inflammation via SIRT1, NLRP3, and AMPK Pathways: A Randomized Controlled Pilot Study

Sumaiah J Alarfaj  1 , Mostafa M Bahaa  2 , Thanaa A Elmasry  3 , Eman I Elberri  4 , Eman El-Khateeb  4 , Amir O Hamouda  5 , Muhammed M Salahuddin  5 , Marwa Kamal  6 , Abdel-Naser Abdel-Atty Gadallah  7 , Nashwa Eltantawy  8 , Mohamed Yasser  9   10   11 , Walaa A Negm  12 , Manal A Hamouda  13 , Amsha S Alsegiani  14 , Sarah Alrubia  14 , Mamdouh Eldesoqui  15 , Mahmoud S Abdallah  16   17
Affiliations
Randomized Controlled Trial

Fenofibrate as an Adjunct Therapy for Ulcerative Colitis: Targeting Inflammation via SIRT1, NLRP3, and AMPK Pathways: A Randomized Controlled Pilot Study

Sumaiah J Alarfaj et al. Drug Des Devel Ther. .

Abstract

Background: Ulcerative colitis (UC) is an idiopathic chronic inflammation of colonic and rectal mucosa. The peroxisome proliferator-activated receptor α (PPARα) has been identified as having protective effects in UC.

Aim: The study aimed to investigate the efficacy of fenofibrate, a PPARα agonist, in UC.

Methods: A total of 70 patients with mild to moderate UC were allocated randomly and assigned to two groups (n = 35 each) from Gastroenterology Department, Faculty of Medicine, Menoufia University. The mesalamine group received a placebo along with 1 g of mesalamine three times daily, while the fenofibrate group received 1 g of mesalamine three times and fenofibrate 160 mg once daily. The study duration was for six months. A gastroenterologist assessed patients by non-invasive Partial Mayo Score (PMS) and the Inflammatory Bowel Disease Questionnaire (IBDQ) to evaluate clinical response and remission. The serum levels of silent information regulator 1 (SIRT1), NOD-like receptor protein 3 (NLRP3), and adenosine monophosphate activated protein kinase (AMPK), as well as fecal calprotectin levels were examined to determine the biological effect of fenofibrate.

Results: After treatment, the fenofibrate group showed statistically significant reductions in PMS (p = 0.044) and improved digestive domain of IBDQ (p = 0.023). Additionally, there were significant decreases in serum NLRP3 (p = 0.041) and fecal calprotectin (p = 0.035), along with significant increases in SIRT1 (p = 0.002) and AMPK (p = 0.0003). The fenofibrate group also had higher response and remission rates compared to the mesalamine group.

Conclusion: Fenofibrate may be a promising adjunct for improving clinical outcomes, quality of life, and modulating inflammation in mild to moderate patients with UC.

Trial registration identifier: NCT05781698.

Keywords: Fenofibrate; Mesalamine; NLRP3/AMPK; PPARα; Ulcerative colitis.

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Conflict of interest statement

The authors have no conflicts of interest.

Figures

Figure 1
Figure 1
CONSORT diagram showing the flow of patients during the study.
See this image and copyright information in PMC

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