Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-12-31

Brief Summary

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Recurrent regurgitation stress the infants and their parents and often results in an inappropirate use of PPI prescription in infancy. The aim of this study is to evaluate the efficacy of Mg alginate in infants with symptoms of gastroesophageal reflux.

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Detailed Description

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Conditions

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Gastro Esophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized controlled cross-over trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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thickened formula

Group Type ACTIVE_COMPARATOR

Mg alginate

Intervention Type DIETARY_SUPPLEMENT

Mg alginate after feedings

Mg alginate

Group Type EXPERIMENTAL

Mg alginate

Intervention Type DIETARY_SUPPLEMENT

Mg alginate after feedings

Interventions

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Mg alginate

Mg alginate after feedings

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised: I-GERQ-R \> 16)
* informed consent signed