Salivary Biomarkers of Gastroesophageal Reflux in Infants

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Salivary Biomarkers of Gastroesophageal Reflux in Infants

Conditions
-----------------
Gastroesophageal Reflux in Infants

Intervention / Treatment
-----------------
* Diagnostic Test: salivary markers


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cases<br>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. | Diagnostic Test: salivary markers<br>* a description of the salivary biochemical profile of GER infants vs. GERD, so that we can develop non-invasive diagnostic strategies and detect personalized therapeutic treatments.<br>|
| No Intervention: controls<br>healthy infants from whom it will be taken a single saliva sample during a health assessment. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD SYMPTOMS | dentify the prevalence of GERD in a cohort of infants with symptoms of gastroesophageal reflux | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIOCHEMICAL PROFILE | Identify any differences in the biochemical profile (pepsin and pepsinogen concentration, electrolyte concentration, such as sodium and HCO3-) of saliva samples collected from healthy, GER and GERD patients. Investigate possible circadian variations in the biochemical profile (see above) of saliva samples collected at different time points during MII-pH performed in GER and GERD infants Correlate the onset of symptoms and nutrition to any changes in the biochemical profile (see above) of saliva samples taken from GER and GERD infants. | 2 years |