Salivary Biomarkers of Gastroesophageal Reflux in Infants
Gastroesophageal Reflux in Infants
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux in Infants
Eligibility Criteria
Inclusion Criteria: Infants with reflux symptoms undergoing MII-pH Consent of parents or legal representative Exclusion Criteria: 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
Sites / Locations
- Policlinico universitario agostino gemelli IRCCSRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
cases
controls
acting from 2 months up to the first year of life, with age 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.
healthy infants from whom it will be taken a single saliva sample during a health assessment.