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Salivary Biomarkers of Gastroesophageal Reflux in Infants

Primary Purpose

Gastroesophageal Reflux in Infants

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
salivary markers
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux in Infants

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

No Intervention

Arm Label

cases

controls

Arm Description

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.

Outcomes

Primary Outcome Measures

GERD SYMPTOMS
dentify the prevalence of GERD in a cohort of infants with symptoms of gastroesophageal reflux

Secondary Outcome Measures

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.

Full Information

First Posted
March 3, 2023
Last Updated
April 6, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05821348
Brief Title
Salivary Biomarkers of Gastroesophageal Reflux in Infants
Official Title
Salivary Biomarkers of Gastroesophageal Reflux in Infants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux in Infants

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cases
Arm Type
Experimental
Arm Description
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.
Arm Title
controls
Arm Type
No Intervention
Arm Description
healthy infants from whom it will be taken a single saliva sample during a health assessment.
Intervention Type
Diagnostic Test
Intervention Name(s)
salivary markers
Intervention Description
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.
Primary Outcome Measure Information:
Title
GERD SYMPTOMS
Description
dentify the prevalence of GERD in a cohort of infants with symptoms of gastroesophageal reflux
Time Frame
2 years
Secondary Outcome Measure Information:
Title
BIOCHEMICAL PROFILE
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina giorgio
Phone
0630155940
Email
valentina.giorgio@policlinicogemelli.it
Facility Information:
Facility Name
Policlinico universitario agostino gemelli IRCCS
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
valentina giorgio
Phone
0630155940
Email
valentina.giorgio@policlinicogemelli.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Salivary Biomarkers of Gastroesophageal Reflux in Infants

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