Evaluation of Immunohistological Pattern in Patients With Uncomplicated Symptomatic Diverticular Disease and Correlation Between Intraluminal Bacterial Flora and Phlogosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Immunohistological Pattern
研究概览
简要总结
Diverticulosis of the colon is a frequent condition in adults in western countries and a significant number of patients experience clinical symptoms even when the diverticulosis is not complicated by diverticulitis.
Both central and mucosal immunity are altered in Uncomplicated Symptomatic Diverticular Disease (USDD) and Rifaximin ameliorate clinical symptoms and normalize the immunological abnormalities.
The Study Protocol is verify the modifications in the immunological pattern induced by reducing bacteria related activation of immunity by Rifaximin treatment.
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
- Single (Investigator)
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
- •male and female
- •age 18 or more
- •radiologic or endoscopic diagnosis of diverticular disease located in sigma or colon descendent
- •Informed consent
- •patients willing to participate in to the study
排除标准
- •other colon diseases
- •Inflammatory Bowel Diseases
- •signs or symptoms of inflammation
- •consumption of : antibiotics, anti-inflammatory drugs ( FANS and 5-ASA), prebiotics, Proton Pump Inhibitors, corticosteroids, fiber within three months
- •pregnancy and breast feeding
- •acute diverticulitis characterized by:
- •moderate/sever pain in left iliac fossa
- •fever > 38°C
- •abdominal pain
- •haematochezia
- •leukocytosis (20% more than the normal range)
- •remote acute diverticulitis
- •rifaximin hypersensitivity
- •neoplastic diseases
- •immunodeficiencies
- •poor physical conditions
- •leaver deficiencies (Child C), kidney (Creatinine>2,2 mg/dl), heart (NYHA 3-4)
- •major psychiatric illness
- •drugs abuses and alcoholism
- •participations in other clinical trials within 4 weeks
- •patients unwillingness certificate
研究组 & 干预措施
1a USDD
Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months
干预措施: Rifaximin (Drug)
结局指标
主要结局
Immunohistological Pattern
时间窗: Two months
Lymphocytes in peripheral Blood, Lymphocytes in the Sigmoid Mucosa, Lymphocytes in the Transverse Mucosa, Monocytes and Granulocytes in Peripheral Blood
次要结局
- Clinical Symptoms(Two Months)
研究者
Guido Costamagna
Director of Digestive and Surgical Endoscopy
Catholic University of the Sacred Heart