Advancing Nutritional Science for Children With Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Dyspepsia Symptom Severity
研究概览
简要总结
This study evaluates four different meals and how they induce gastrointestinal symptoms in children with functional dyspepsia. All subjects will receive each meal and rate their gastrointestinal symptoms during each meal.
详细描述
Food can often exacerbate gastrointestinal symptoms in adults and children with functional dyspepsia. However, it is unclear which foods exacerbate symptoms more than others.
Children with post-prandial distress functional dyspepsia will receive four different meals with variables being: semi-solid vs. solid and high fat vs high carbohydrate. At the time of ingestion and for up to 3 hours after each meal, subjects will rate their gastrointestinal symptoms. Comparisons of symptom onset and severity will be made for each meal.
Enrolled subjects will have undergone previous gastrointestinal evaluations: gastric emptying study and/or upper endoscopy. In addition, subjects will complete psychosocial measures: Behavioral Assessment for Children-3, childhood somatization inventory.
The first goal is to compare the severity of gastrointestinal symptoms with different composition and consistency meals. The second goal is to correlate the severity of postprandial gastrointestinal symptoms to psychosocial distress, gastric neuromotor function (emptying and accommodation), and duodenal inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Meals will be provided in a randomized fashion with only the metabolic research unit kitchen (which prepares the meals) knowing what is being provided to the subject.
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rome IV Functional Dyspepsia with post-prandial distress
- •Previously completed normal upper endoscopy with duodenal biopsies and/or previously completed a gastric emptying scintigraphy study
排除标准
- •Previous abdominal surgery
- •Current or previous formal psychiatric diagnosis (e.g. anxiety disorder) requiring therapy or psychotropics
- •Serious chronic medical condition requiring regular medical care
- •Allergy to meal components to be ingested during the study
- •On specialized diet required for a medical condition
- •Pregnancy
- •Inability to eat by mouth
结局指标
主要结局
Dyspepsia Symptom Severity
时间窗: up to 16 weeks
Change from baseline gastrointestinal symptoms using total visual analogue scale score
次要结局
- Gastric accommodation(up to 16 weeks)
- Dyspepsia Symptom Onset(up to 16 weeks)
- Psychosocial distress(up to 16 weeks)
- Duodenal inflammation(up to 16 weeks)
- Gastric retention(up to 16 weeks)
研究者
Bruno Chumpitazi
Associate Professor
Baylor College of Medicine