Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.

Policlinico Hospital99 enrolled

Overview

A randomized controlled cross-over trial in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised). The parents of all of the enrolled infants will be reassured on the benign nature of the condition and will advise to apply lifestyle changes for one week. Than, the patients will be randomized into one of the two sequence treatment groups. (group A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks. Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gastroesophageal Reflux

Interventions

thickened formulaDIETARY_SUPPLEMENT

Mg alginateDIETARY_SUPPLEMENT

reassurance with lifestyle changesBEHAVIORAL

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 1 YearHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * full-term ages 3 to 12 months, affected by symptoms suggestive of GER. * infant regurgitation defined according to the Rome IV criteria * informed consent Exclusion Criteria: * Evidence of chronic diseases, hepatic, renal, or cardiac diseases, metabolic or central nervous system diseases, or use of acid suppressor treatment (H2-receptor antagonists or proton pump inhibitors \[PPIs\]), thickened formula, or a history of prematurity or atopy

Locations (1)

Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital

Bari, Italy

Outcomes

Primary Outcomes

Evaluation of symptom scores

Infant Gastroesophageal Reflux Questionnaire Revised

Time frame: From day 0 to day 35

Data from ClinicalTrials.gov

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