Clinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL)
研究概览
简要总结
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.
详细描述
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however the exact underlying mechanisms of UC remain poorly understood. UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.
PPARα has been proposed as a key lipid metabolism modulator and regulator of inflammation. There are three isotypes of PPAR (α, β and ȣ) which have distinct but overlapping functions.
Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment for 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control Group
Mesalamine group will receive 1 g mesalamine three times daily for 6 months
干预措施: Mesalamine (Drug)
Fenofibrate group
Fenofibrate group will receive 1 g mesalamine three times daily plus Fenofibrate (160 mg/day) for 6 months
干预措施: Fenofibrate 160mg (Drug)
结局指标
主要结局
The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL)
时间窗: 6 months
HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms.
次要结局
- The secondary endpoint is estimated by changes in serum interleukin (IL-6) and nitric oxide (NO)(6 months)
研究者
Mostafa Bahaa
Teaching Assistant
Tanta University