Association Between Lactase Deficiency, Symptoms of Lactose Intolerance, and the Small Intestinal Microbiome in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Lactase activity
研究概览
简要总结
The purpose of this study is to study the role of the enzyme (substance produced by the body that helps in a biochemical reaction like digestion in the body) responsible for digestion of lactose and the role of the gut bacteria (bacteria in the intestine) in producing symptoms of lactose intolerance.
详细描述
The study involves 3 visits and will include 2 types of subjects - those who have the the diagnosis of lactose intolerance (subjects) and those who do not have lactose intolerance (controls).
Visit 1:
In total, it is estimated that the research participation will add about 1 hour to your planned procedure visit. At Visit 1 following will be done
- Subjects will be asked to read and sign the informed consent after all the questions about the study have been answered.
- General medical history will be taken including demographics, symptoms and history of illness, and medication review.
- Vital signs (blood pressure, temperature, respiration, height, and weight) will be recorded.
- Subjects will be asked to complete 2 questionnaires
- Upper endoscopy will be done as part of routine clinical care
- At the time of the endoscopy 4 extra biopsies (small piece of tissue) from the small intestines will be taken. The biopsies will be used for research to detect the bacteria and to measure the lactase enzyme.
- Small sample of blood (10 mL) (2 teaspoons) will be taken for storage for possible future testing. This will be a one time draw only.
- The research team may contact the subjects to arrange a Visit 2 if they are interested in proceeding with the next step in this research study.
Visit 2:
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Lactase activity
时间窗: 1 day
Lactase activity (µmol/min/g) will be assessed from small bowel biopsy specimens
次要结局
- Symptom severity(1 day)
- Small intestinal mucosal microbiome(1 day)
- Maldigestion status(1 day)
- Fecal microbiome(1 day)
研究者
Huiping Xu
Associate Professor
Indiana University
