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临床试验/NCT05055336
NCT05055336撤回不适用

Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia: Toward Individualized Care in Functional Abdominal Pain Disorders

University of Miami0 个研究点开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Gastric emptying rate

研究概览

简要总结

The purpose of this research is to further study the relationship between gastroparesis (GP) (a condition in which the stomach cannot empty itself of food in a normal fashion) and functional dyspepsia (FD) (frequent symptoms of indigestion that have no obvious cause).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Able to complete the Pediatric Cardinal Symptoms Questionnaire
  • Both parent and child must be able to speak and understand English or Spanish

排除标准

  • Have global developmental delay, autism disorder, or psychosis
  • Are nonverbal and/or illiterate
  • Lack fluency in English or Spanish
  • Have other GI comorbidities such as inflammatory bowel disease, celiac disease, eosinophilic esophagitis, peptic ulcer disease, GI malignancy, or gastroesophageal reflux disease responsive to medications (medical records will be reviewed to detect these exclusions)
  • Have a history of surgical procedures that could have potentially affected their GI tract anatomy, such as fundoplication or Ladd's procedure.
  • Healthy child presenting to their well child care visit must not report a history of dyspepsia, have a history of any gastrointestinal disease, or be taking any medication that can disturb the GI tract motility.

结局指标

主要结局

Gastric emptying rate

时间窗: up to 6 months

As measured by the spirulina breath test

次要结局

  • Pediatric Cardinal Symptoms Questionnaire Scores(Up to 6 months)
  • Percentage of food retained in the stomach(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

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