Evaluation of Liquid Gastric Emptying and Plasma Ghrelin in Children With Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Children with FD: exploration of relationships between ghrelin concentration, liquid gastric emptying, and dyspepsia subtype
研究概览
简要总结
The purpose of this research is to see if there are differences between children who have FD and children without FD in the ability of the stomach to empty food and/or in ghrelin hormone levels before and after eating.
Chronic abdominal pain is the most common persistent pain condition in children and adolescents. One of the most often diagnosed types of abdominal pain is functional dyspepsia (FD). FD is abdominal pain or discomfort (e.g., nausea, bloating) in the upper abdomen that does not get better by having a bowel movement.
One possible explanation for having FD is a delay in the emptying of food from the stomach, or delayed gastric (stomach) emptying. Failing to empty the stomach quickly enough may result in the feeling of being full and cause symptoms of bloating, nausea, vomiting and pain. Further, hormonal changes occur before, during, or after eating food that appear to impact stomach emptying.
One of the hormones that changes with meals is called ghrelin. The relationship between ghrelin and stomach emptying needs to be explored more in children with FD. Better understanding of what causes FD symptoms may help us to improve treatment for this condition.
详细描述
Functional Dyspepsia (FD) is defined as the presence of persistent or recurrent pain or discomfort centered in the upper abdomen with no evidence of organic disease likely to explain the symptoms.
This pain or discomfort must not be exclusively relieved by defecation or associated with the onset of a change in stool frequency or stool form.
Initially, the FD classification criteria included 3 subtypes: ulcer-like, in which pain is the predominant symptom; dysmotility-like, in which discomfort is the predominant symptom; and, unspecified. In 2006, however, the criteria were revised by the Rome III committees. In adults, the previous FD subtypes were eliminated and replaced by two new subtypes: (i) postprandial distress syndrome (PDS), characterized by postprandial fullness or early satiety; and, (ii) epigastric pain syndrome (EPS), characterized by epigastric pain or burning unrelated to meals. In children, the Rome II subtypes were eliminated completely. Although the Rome III subtypes have only been applied within adult criteria, there also appear to be meaningful associations in children with FD which may support their adoption in later revisions of the criteria. Specifically, both inflammation (reflected by mast cell density) and self reported anxiety and depression appear to be uniquely associated with PDS in children.
FD is a common disorder of the upper gastrointestinal (GI) tract, occurring in 26% to 34% of the general population. FD is present in as many as 80% of children being evaluated for chronic abdominal pain. FD is best explained by a biopsychological model with dysfunction within the brain-gut axis. The model suggests that FD is as a result of interaction between biological (e.g., inflammation, mechanical, or sensory dysfunction), psychological (e.g., anxiety, depression, somatization), and social (e.g., interactions with parents, teachers, or peers) factors, which may be interactive with each other. Delayed gastric emptying is one of the mechanical factors which have been implicated. Other mechanisms are visceral hypersensitivity and impaired gastric fundic accommodation.
Delayed gastric emptying has been shown in up to 66% of children with FD. Most of previous studies in children used solid GE as a measure to explain the function of pyloric emptying. However, liquids GE is a good measure to predict the function of fundic accommodation, visceral hypersensitivity as well as pyloric emptying, in which, all these mechanisms were suggested in the mechanical pathophysiological model of FD specifically PDS subtypes. In order to measure gastric emptying (GE), the 13C-acetate breath test (ABT) has the potential to replace 99mtechnetium colloid-based scintigraphy which is the "gold standard" for measuring GE. ABT has an advantage over scintigraphy in that it is a rapid, technically simple, safe and inexpensive means to assess liquid GE in children. As such, it may be more easily utilized as a diagnostic technique in standard clinical practice.
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
- 8 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All: Participants 8-17 years of age
- •FD arms: Patients identified in CMH/Abdominal Pain Team Clinic with Functional Dyspepsia who meet exclusion criteria.
- •Control arm: healthy participants who meet exclusion criteria.
排除标准
- •History of upper gastrointestinal surgery or intestinal obstruction.
- •History of disease or symptoms suggestive of underlying malabsorption, Inflammatory Bowel Disease (IBD), or Peptic Ulcer Disease (PUD).
- •History or evidence of chronic illness requiring regular medical care such as diabetes mellitis (DM), liver, heart, kidney, endocrine, or pulmonary disease and asthma that precludes accurate exhalation into the study breath collection apparatus.
- •Any patient with body Mass index (BMI) less than or equal to 10th percentile for age; or equal to or greater than 90th percentile for age.
- •Patient and/or parent not able to read English.
- •Current pregnancy.
- •History of milk allergy.
- •Prokinetic or psychotropic medications used within the last 72 hour prior to study.
- •Inability to exhale into study breath collection apparatus as directed.
- •Recent acute illness that occurs prior to study visit.
结局指标
主要结局
Children with FD: exploration of relationships between ghrelin concentration, liquid gastric emptying, and dyspepsia subtype
时间窗: Duration of 4-hour study visit
Blood samples will be compared pre/post test meal for FD cohorts (EPS/PDS), controls: 0 time/baseline; 6 times/post meal. Associations between relationship of plasma ghrelin type's (acyl and desacyl) pre and postprandial levels \& gastric emptying studied.C-13 acetate to be given and amount of 13CO2 determined for each time point (1 pre/ 14 post meal) using equation nested in software package with UBit IR-300 spectrometer. The concentration of 13CO2 and 12CO2 in the exhaled breath samples to be measured by infrared spectrometry.
次要结局
- Children with FD: SUBJECTIVE SYMPTOM SEVERITY and correlations between plasma ghrelin concentrations (acyl and desacyl) and gastric emptying.(Duration of 4-hour study visit)
研究者
Nadia Hijaz
MD, Fellow, Children's Mercy Hospital, Section of Gastroenterology
Children's Mercy Hospital Kansas City
