跳至主要内容
临床试验/NCT03470181
NCT03470181已完成不适用

Applying Nutrient Drink Test in Understanding Pathophysiology of Cyclic Vomiting Syndrome

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年2月1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
24
试验地点
1
主要终点
Maximum tolerated volume

研究概览

简要总结

Cyclic vomiting syndrome is a disorder characterized by nausea and vomiting, separated by periods without any symptoms. There is very little research on this field at this point and most doctors do not fully understand the disorder. The goal of this study is to assess how the stomach empties food. Participants will be asked to participate in this study because either (a) they have been diagnosed and/or treated for cyclic vomiting syndrome in the past, or (b) they are physically healthy. The study seeks to compare how a healthy person's stomach empties to how the stomach of someone with cyclic vomiting disorder empties.

详细描述

Up to 14% of unexplained vomiting in adults is attributed to an under recognized and often misdiagnosed disorder termed cyclic vomiting syndrome (CVS). As CVS is better understood, gastroenterologists are increasingly recognizing the importance of timely diagnosis and early management for this chronic and debilitating disorder. Currently, the only gold standard diagnostic strategy involves evaluating clinical criteria set by the Rome Foundation, such as vomiting frequency and duration of episodes. Outside of these subjective criteria, no definitive and objective diagnostic strategy for cyclic vomiting syndrome exists.

Developing diagnostic strategies has been difficult given the exact etiology of CVS is still unknown. One physiologic theory includes rapid gastric emptying (GE)-or a dumping-like syndrome related to impaired gastric accommodation. A retrospective analysis observed rapid gastric emptying by standard 4-hour scintigraphic gastric emptying study in 80% of subjects, suggesting a relationship with CVS and rapid GE. In turn, rapid emptying has been hypothesized to relate with abnormal gastric accommodation - the reflex allowing storage of food through increased fundic volume. This physiologic abnormality can be readily and easily measured using non-invasive tools, but have never been tested in CVS. To explore this further, we aim to determine if CVS patients have abnormal gastric accommodation measured by nutrient drink test.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Cyclic Vomiting (or Healthy Volunteer)
  • Age 18 or greater

排除标准

  • Age Under 18
  • History of gastric surgery
  • History of marijuana use
  • History of Gastroparesis
  • History of Diabetes mellitus II
  • Upper endoscopy with known obstructive gastric disease
  • Current pregnancy or lactation
  • Active inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
  • Severe renal disease (GFR <15/dialysis dependent)
  • Active malignancy (diagnosed in last 5 years)
  • Allergy/intolerance to liquid Ensure®

结局指标

主要结局

Maximum tolerated volume

时间窗: Within 30 minutes of beginning the test.

The amount of nutrient drink consumed before the participant reports feelings of unbearable fullness.

次要结局

  • Total Aggregate Symptom Score(Within 30 minutes of the beginning of the test)

研究者

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

Scott Gabbard, MD

Staff

The Cleveland Clinic

研究点 (1)

Loading locations...

相似试验

Applying Nutrient Drink Test in Understanding... | 临床试验