Salivary Biomarkers of Gastroesophageal Reflux in Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- GERD SYMPTOMS
研究概览
简要总结
Gastroesophageal reflux (GER), defined as the backflow of gastric material into the esophagus, it is a condition with a high prevalence during the first year of life. The disease from Gastroesophageal reflux (GERD), a rarer condition, is defined as the presence of symptoms and complications caused by gastroesophageal reflux. For the diagnosis of GERD in infants it is necessary to perform instrumental diagnostic tests invasive. Several efforts have already been made to identify diagnostic strategies non-invasive but, at the state of the art, no non-invasive biomarker has yet been found of GERD in infants. Therefore, the aim of this pilot study is to identify possible biomarkers salivary gastroesophageal reflux in a population of infants with GER or GERD. Infants from 2 months to the first year of life, with age, will be prospectively enrolled postmenstrual > 40 weeks, hospitalized, with symptoms of GER or GERD and undergoing 24-hour esophageal MII-pH.
Saliva samples will be collected during the execution of the MII-pH of the esophagus 24 hours, at defined time points, at least 2 hours after the last meal, so as to study the circadian variations of their composition.
A control group made up of healthy infants will also be enrolled and will be sampled a single saliva sample during a health assessment. The salivary pH, the buffer capacity, the electrolytes (Na, K, Cl, HCO3) and the saliva pepsin/pepsinogen concentrations of enrolled infants. The expected results include the description of the salivary biochemical profile of GER infants vs. GERD, so that the investigators can develop non-invasive diagnostic strategies and detect personalized therapeutic treatments.
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
- 1 Month 至 12 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with reflux symptoms undergoing MII-pH
- •Consent of parents or legal representative
排除标准
- •Infants being treated with PPIs
- •Infants with postmenstrual age < 40 weeks
- •Infants with gastrointestinal disorders/diseases other than functional gastrointestinal disorders (FGID)
- •Infants with otorhinolaryngological conditions potentially capable of altering salivary composition
- •Infants with gastrointestinal malformations, such as esophageal atresia
- •Infants with genetic, neurological, renal or endocrinological disorders
- •Infants for whom the collection of salivary samples is not feasible
结局指标
主要结局
GERD SYMPTOMS
时间窗: 2 years
dentify the prevalence of GERD in a cohort of infants with symptoms of gastroesophageal reflux
次要结局
- BIOCHEMICAL PROFILE(2 years)
研究者
Giorgio Valentina
principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
