Clinical trial NCT05821348: Salivary Biomarkers of Gastroesophageal Reflux in Infants
Official title: Salivary Biomarkers of Gastroesophageal Reflux in Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux in Infants
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 43
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: GERD SYMPTOMS
timeFrame: 2 years
Secondary outcomes:
measure: BIOCHEMICAL PROFILE
timeFrame: 2 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico universitario agostino gemelli IRCCS
Study officials:
References: