Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia: Toward Individualized Care in Functional Abdominal Pain Disorders
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
- 是
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.
研究组 & 干预措施
Gastroparesis
Participants in this group are children diagnosed with gastroparesis per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.
干预措施: Gastric emptying breath test (Other)
Gastroparesis
Participants in this group are children diagnosed with gastroparesis per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.
干预措施: Stomach ultrasound (Other)
Dyspepsia
Participants in this group are children diagnosed with functional dyspepsia per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.
干预措施: Gastric emptying breath test (Other)
Dyspepsia
Participants in this group are children diagnosed with functional dyspepsia per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.
干预措施: Stomach ultrasound (Other)
Healthy Controls
Participants in this group are children that do not have gastroparesis, functional dyspepsia, or any other gastroenterology condition. Participants will be getting an ultrasound once.
干预措施: Stomach ultrasound (Other)
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
- Percentage of food retained in the stomach(Day 1)
- Pediatric Cardinal Symptoms Questionnaire Scores(Up to 6 months)