Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary endpoint is the improvement in health-related quality of life
研究概览
简要总结
Ulcerative colitis (UC) is one of the most common types of chronic and non-specific inflammatory bowel diseases (IBD). It is characterized by cytokine-induced continuous and diffuse inflammatory infiltrations into the rectum's mucosa and extends proximally to the colon. Patients with UC predominantly have bloody diarrhea, abdominal pain, fecal urgency, and tenesmus, which extremely alters their quality of life.
Although the precise pathological mechanism of UC remains unclear, several studies have been outlined many factors that could involve in the pathogenesis of UC, including, but not limited to, initiation of the inflammatory response, disruption of oxidant/antioxidant status, dysregulation of the immune response, alteration of gut microbiota, and delaying epithelial barrier healing. Loss of intestinal barrier function and dysregulated immune response are the key events during colitis development
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, Care Provider)
盲法说明
double blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Both male and female will be
- •Mild and moderate UC patients diagnosed and confirmed by endoscope
排除标准
- •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
研究组 & 干预措施
Nifuroxazide group
Patients will receive 1 g mesalamine three times daily plus Nifuroxazide 200 mg two times daily for 6 months
干预措施: Mesalamine (Drug)
control group
Control group (Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months
干预措施: Mesalamine (Drug)
Nifuroxazide group
Patients will receive 1 g mesalamine three times daily plus Nifuroxazide 200 mg two times daily for 6 months
干预措施: Nifuroxazide (Drug)
结局指标
主要结局
The primary endpoint is the improvement in health-related quality of life
时间窗: 6 months
The IBDQ includes 32 questions, The questions are grouped into four categories: bowel symptoms (B), systemic symptoms (S), emotional function (E), and social function (SF). Response options are consistently presented as seven-point scales, scores range from 32-224
次要结局
未报告次要终点
研究者
Mostafa Bahaa
Teaching assisstant
Tanta University