Developing an Approach to Perturbation of Human Small Intestinal and Colonic Permeability in Healthy Participants
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in urinary excretion of 13^C-mannitol
研究概览
简要总结
The purpose of this study is to evaluate the effect of castor oil versus placebo on intestinal permeability in healthy individuals.
详细描述
Randomized, parallel-group, placebo-controlled, blinded, dose-response study using Castor oil and see the effects it has on small bowel and colonic permeability measured in healthy female and male adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Healthy, non-obese, non-pregnant volunteers.
- •1:1 Male/Female Ratio.
- •BMI < 30 kg/m^2.
排除标准
- •Diabetes.
- •Uncontrolled hypertension (with BP measured > 140/90mmHg in the CRTU)
- •BMI ≥ 30 kg/m^
- •Chronic NSAID use (> 1 day/week).
- •Use of oral antibiotics for 2 weeks prior to and during the entire 5 day study period.
- •Known intolerance of castor oil.
- •Diagnosis of gastrointestinal diseases that are associated with abnormal intestinal or colonic permeability such as inflammatory bowel diseases, irritable bowel syndrome and celiac disease.
- •Prior intestinal or colonic resection.
- •Participation in highly vigorous exercise such as running > 5 miles per day in week prior to the permeability test.
研究组 & 干预措施
750 mg castor oil treatment group
Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days
干预措施: Ricinoleic Acid 750 mg (Dietary Supplement)
1500 mg castor oil treatment group
Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days
干预措施: Ricinoleic Acid 1500 mg (Dietary Supplement)
3000 mg castor oil treatment group
Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days
干预措施: Ricinoleic Acid 3000 mg (Dietary Supplement)
Placebo group
Subjects will take placebo daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in urinary excretion of 13^C-mannitol
时间窗: 0-2 hours, 2-8 hours and 8-24 hours
Percent urinary excretion of 13\^C-mannitol
次要结局
- Change in urinary excretion of lactulose(0-2 hours, 2-8 hours and 8-24 hours)
研究者
Michael Camilleri, MD
Principal Investigator
Mayo Clinic