跳至主要内容
临床试验/NCT06066866
NCT06066866尚未招募不适用

Microbiome Sampling in GI Disease With a Focus on Small Intestinal Microbial Assessment

Stanford University0 个研究点目标入组 150 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
主要终点
Ability to isolate live bacteria from 95% of samples

研究概览

简要总结

GI disorders are influenced by the gut microbiome. To date, sampling of the small intestine in GI disorders has been limited. The investigators plan to sample the small intestinal contents during endoscopy for research purposes.

详细描述

Current guidelines (AGA Clinical Practice Update, 2020) report the definition of SIBO as a clinical entity lacks precision and consistency; it is a term generally applied to a clinical disorder where symptoms, clinical signs, and/or laboratory abnormalities are attributed to changes in the numbers of bacteria or in the composition of the bacterial population in the small intestine. To date, there is unlimited knowledge regarding the diagnostic criterion which has been limited by nonspecific and nonsensitive testing such as breath tests. Breath tests have a limited use in patients with IBS-D who inherently have increased gut transit time rendering the testing invalid for accurately measuring small intestinal bacteria. Additionally, the relationship between SIBO and symptoms in patients without obvious risk factors (such as anatomical changes due to surgery) is unknown. The investigators study aims to investigate the microbial landscape of the small intestine in healthy patients and those with GI disease (suspected or diagnosed) undergoing an upper endoscopy by collecting an aspirate of patient small intestinal fluid and studying it.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18years
  • Patients seen at Stanford University Digestive Health Center who are scheduled for an upper endoscopy as part of their Standard Of Care

排除标准

  • Children (under age 18years) Pregnant Women and Fetuses Neonates (0 - 28 days) Impaired Decision Making Capacity

结局指标

主要结局

Ability to isolate live bacteria from 95% of samples

时间窗: 1-4 years

We aim to isolate live bacteria from 95% of samples

次要结局

  • Ability to measure quantitative Colony Forming Units (CFUs) in 90% of samples(1-4 years)

研究者

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

Sean Spencer

Instructor, Stanford Gastroenterology and Hepatology

Stanford University

相似试验