Salivary Biomarkers of Gastroesophageal Reflux in Infants
NCT ID: NCT05821348
Last Updated: 2023-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
43 participants
INTERVENTIONAL
2021-10-21
2023-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
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.
controls
healthy infants from whom it will be taken a single saliva sample during a health assessment.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Consent of parents or legal representative
Exclusion Criteria
* 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
1 Month
12 Months
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Giorgio Valentina
principal investigator
Locations
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Policlinico universitario agostino gemelli IRCCS
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GLORIA
Identifier Type: -
Identifier Source: org_study_id
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