Evaluation of Microbiota and Probiotic Therapy in Ulcerative Colitis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Clinical Activity Index
研究概览
简要总结
This study aimed to evaluate the role of microbiota and probiotics in Egyptian patients with ulcerative colitis.
详细描述
Inflammatory bowel disease (IBD) is a group of chronic diseases that significantly affects patients' quality of life and is mainly represented by Crohn's disease (CD) and ulcerative colitis (UC).
The microbiome is a key contributor to various fundamental aspects of human health, including host metabolism, infection, and the immune response.
Changes in microbiome composition have been linked to complex multifactorial diseases, e.g., type 2 diabetes, metabolic syndrome, and non-alcoholic fatty liver syndrome, as well as inflammatory bowel disease (IBD).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients more than 18 years.
- •Patients with ulcerative colitis in remission as assessed by the clinical activity index (CAI) ≤ 4, endoscopic index (EI) ≤ 4, and no signs of acute inflammation on histological examination.
排除标准
- •Active ulcerative colitis.
- •Cardiac, hepatic, or renal disease.
- •Pregnancy.
- •History of major colonic surgery.
- •Patients with any malignancy.
- •Previously taking other probiotics.
- •Use of steroids within the last 4 weeks before study entry.
- •Use of antibiotics within the last 2 weeks before study entry
研究组 & 干预措施
Group I
Patients with ulcerative colitis in remission treated with oral mesalamine.
干预措施: Mesalamine (Drug)
Group II
Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii).
干预措施: Probiotics (Bacillus Clausii) (Drug)
Group III
Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii).
干预措施: Mesalamine and probiotics (Bacillus Clausii) (Drug)
结局指标
主要结局
Clinical Activity Index
时间窗: 12 months post-procedure
The clinical activity index (CAI) is a tool that assesses disease activity in patients with ulcerative colitis. Seven clinical features are evaluated, with the total index score ranging from 0 to 25: 0 to 4 inactive (remission); 5 to 10 mild activity; 11 to 17 moderate activity; and ≥ 18 high activity. CAI was measured at the study start and every 3 months through the follow up period (1year)
次要结局
- Body Mass Index(12 months post-procedure)
- Gut Microbiota(12 months post-procedure)
研究者
Al Shaimaa Fathy El desouky
Assistant Lecturer of Tropical Medicine & Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University