Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary endpoint is the change in mayo score
研究概览
简要总结
The inflammatory bowel diseases (IBD) are described as complex, recurrent inflammatory conditions which are manifested as Crohn's disease (CD) and ulcerative colitis (UC). The common symptoms of IBD include debilitating/severe diarrhea, abdominal pain, weight loss, and chronic fatigue; events that may culminate in life-threatening complications. The pathogenesis of IBD has been characterized as complex/multi-factorial that includes disruption of intestinal epithelial barrier with consequent translocation of commensal microbial products as the prime event that instigates severe immune responses and intestinal inflammation.
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-blinded
入排标准
- 年龄范围
- 18 Months 至 60 Years（Child, 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
- •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 dapagliflozin
研究组 & 干预措施
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)
Dapagliflozin group
Patients will receive 1 g mesalamine three times daily plus dapagliflozin 10 mg once daily for 6 months
干预措施: Mesalamine (Drug)
Dapagliflozin group
Patients will receive 1 g mesalamine three times daily plus dapagliflozin 10 mg once daily for 6 months
干预措施: Dapagliflozin 10mg Tab (Drug)
结局指标
主要结局
The primary endpoint is the change in mayo score
时间窗: 6 months
The Mayo score is one of the most commonly used disease activity indices in placebo-controlled trials in UC. In its complete form, it is composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance
次要结局
未报告次要终点
研究者
Mostafa Bahaa
Teaching assisstant
Tanta University