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临床试验/NCT03860051
NCT03860051已完成不适用

Association Between Lactase Deficiency, Symptoms of Lactose Intolerance, and the Small Intestinal Microbiome in Adults

Indiana University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2018年11月21日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huiping Xu

Associate Professor

Indiana University

研究点 (1)

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