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Randomized Controlled Trial
. 2019 Dec 20;17(1):83.
doi: 10.3390/ijerph17010083.

Magnesium Alginate in Gastro-Esophageal Reflux: A Randomized Multicenter Cross-Over Study in Infants

Maria Elisabetta Baldassarre  1 , Antonio Di Mauro  1 , Maria Cristina Pignatelli  1 , Margherita Fanelli  2 , Silvia Salvatore  3 , Giovanni Di Nardo  4 , Andrea Chiaro  5 , Licia Pensabene  6 , Nicola Laforgia  1
Affiliations
Randomized Controlled Trial

Magnesium Alginate in Gastro-Esophageal Reflux: A Randomized Multicenter Cross-Over Study in Infants

Maria Elisabetta Baldassarre et al. Int J Environ Res Public Health. .

Abstract

The aims of this study were to evaluate the efficacy of magnesium alginate in decreasing functional regurgitation symptoms in infants, and to assess the cost-benefit ratio of magnesium alginate compared to a thickened formula. A multicenter perspective cross-over study was conducted in formula-fed infants with persisting regurgitation, randomly assigned to receive two weeks of a magnesium-alginate-based formulation followed by two weeks of thickened formula, or vice-versa. Infants, exclusively breast-fed, were followed up for two weeks while receiving magnesium alginate. Symptoms of gastroesophageal reflux (GER) were evaluated through the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R). Direct cost of treatments was also calculated. Seventy-two infants completed the study. We found a significant reduction of I-GERQ-R scores over time (F = 55.387; p < 0.001) in all groups with no difference between the sequences of administration (F = 0.268; p = 0.848) in formula-fed infants and between exclusively breast-fed and formula-fed infants receiving magnesium alginate (t = 1.55; p = 0.126). The mean cost savings per infant was € 4.60 (±11.2) in formula-fed infants treated with magnesium alginate compared to thickened formula (t = 2.91, p < 0.0005). Conclusions were that the magnesium-alginate formulation reduces GER symptoms both in formula-fed and breast-fed infants. In formula-fed infants, clinical efficacy is similar to thickened formulas with a slightly lower cost of treatment.

Keywords: breastfeeding; infant regurgitation; magnesium alginate; thickened formula.

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Conflict of interest statement

Maria Elisabetta Baldassarre is a scientific consultant for Aurora Biofarma.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Study flow. GER: gastroesophageal reflux; I-GERQ-R: Infant Gastro-Esophageal Reflux Questionnaire.
See this image and copyright information in PMC

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