跳至主要内容
临床试验/NCT05821348
NCT05821348招募中不适用

Salivary Biomarkers of Gastroesophageal Reflux in Infants

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2021年10月21日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giorgio Valentina

principal investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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