Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.

Phase 3

Completed

• Conditions: Gastro Esophageal Reflux
• Interventions: Dietary Supplement: Mg alginate

• Registration Number: NCT03881722
• Lead Sponsor: Policlinico Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2018-02-17
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-18
• Last Update Submitted: 2019-03-18
• Study First Posted: 2019-03-19
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

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

Exclusion Criteria

• congenital or chronic diseases
• use of anti acid drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
thickened formula	Mg alginate	-
Mg alginate	Mg alginate	-

Primary Outcome Measures

Name	Time	Method
Infant Gastro-Esophageal Reflux Questionnaire Revised	through study completion, an average of 1 month	12-item validated questionnaire called Infant Gastro-Esophageal Reflux Questionnaire Revised (I-GERQ-R) which include different questions about regurgitation, crying, feeding and respiratory problems

Trial Locations

Locations (1)

Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital; 🇮🇹 Bari, Italy