Salivary Biomarkers of Gastroesophageal Reflux in Infants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: cases 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
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.
|
| No Intervention: controls healthy infants from whom it will be taken a single saliva sample during a health assessment. |
Outcome Measures
Primary Outcome Measures
- GERD SYMPTOMS [2 years]
dentify the prevalence of GERD in a cohort of infants with symptoms of gastroesophageal reflux
Secondary Outcome Measures
- BIOCHEMICAL PROFILE [2 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Infants with reflux symptoms undergoing MII-pH
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Consent of parents or legal representative
Exclusion Criteria:
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Infants being treated with PPIs
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Infants with postmenstrual age < 40 weeks
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Infants with gastrointestinal disorders/diseases other than functional gastrointestinal disorders (FGID)
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Infants with otorhinolaryngological conditions potentially capable of altering salivary composition
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Infants with gastrointestinal malformations, such as esophageal atresia
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Infants with genetic, neurological, renal or endocrinological disorders
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Infants for whom the collection of salivary samples is not feasible
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Policlinico universitario agostino gemelli IRCCS | Roma | Italy |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GLORIA