Gut Permeability, Sensitivity and Symptomatology: Is There a Link and Explanation for Exacerbation of Symptoms Post Meals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Mean Percent of complete epithelial cell loss
研究概览
简要总结
To better understand the relationship between gut barrier function and the symptomatology and pathophysiology of irritable bowel syndrome (IBS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 70 years
- •No abdominal surgery (except appendectomy, cholecystectomy, hernia repair, hysterectomy, and C-section).
- •Written informed consent
排除标准
- •Females who are pregnant or breastfeeding
- •Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- •Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)
- •Use of oral corticosteroids within the previous 6 weeks
- •Ingestion of artificial sweeteners such as Splenda (sucralose), Nutrasweet (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g. foods to be avoided are sugarless gyms or mints and diet soda.
- •Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before the study begins.
- •Proton pump inhibitors.
- •Antibiotics for the preceding 60 days before the start of the study.
- •(vii) Alcohol intake beyond the recommended safe limit (<21 unites per week)
- •Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
- •Known allergy to fluorescein
- •Inflammatory bowel diseases, celiac disease.
研究组 & 干预措施
Healthy Volunteers
Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.
干预措施: Gastrointestinal Permeability Test (Procedure)
Healthy Volunteers
Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.
干预措施: Upper Endoscopy (Procedure)
Healthy Volunteers
Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.
干预措施: Rectal Barostat and Infusion of Fats (Procedure)
Irritable Bowel Syndrome Patients
Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.
干预措施: Gastrointestinal Permeability Test (Procedure)
Irritable Bowel Syndrome Patients
Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.
干预措施: Upper Endoscopy (Procedure)
Irritable Bowel Syndrome Patients
Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.
干预措施: Rectal Barostat and Infusion of Fats (Procedure)
结局指标
主要结局
Mean Percent of complete epithelial cell loss
时间窗: 72 hours
次要结局
未报告次要终点
研究者
Madhusudan (Madhu) Grover, MBBS
Assistant Professor of Medicine
Mayo Clinic