Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.

Phase 4

• Conditions: Gastroesophageal Reflux
• Interventions: Dietary Supplement: thickened formula; Dietary Supplement: Mg alginate; Behavioral: reassurance with lifestyle changes

• Registration Number: NCT02806453
• Lead Sponsor: Policlinico Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-06
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-16
• Last Update Submitted: 2016-06-19
• Study First Posted: 2016-06-20
• Last Update Posted: 2016-06-21
• Study Start: 2016-07
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	thickened formula	Group A: Mg alginate/thickened formula
Group A	reassurance with lifestyle changes	Group A: Mg alginate/thickened formula
Group B	reassurance with lifestyle changes	Group B: thickened formula/Mg alginate
Group B	thickened formula	Group B: thickened formula/Mg alginate
Group B	Mg alginate	Group B: thickened formula/Mg alginate
Group A	Mg alginate	Group A: Mg alginate/thickened formula

Primary Outcome Measures

Name	Time	Method
Evaluation of symptom scores	From day 0 to day 35	Infant Gastroesophageal Reflux Questionnaire Revised

Trial Locations

Locations (1)

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