Dataset Information

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

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.

SUBMITTER: Baldassarre ME

PROVIDER: S-EPMC6981691 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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

Baldassarre Maria Elisabetta ME Di Mauro Antonio A Pignatelli Maria Cristina MC Fanelli Margherita M Salvatore Silvia S Di Nardo Giovanni G Chiaro Andrea A Pensabene Licia L Laforgia Nicola N

International journal of environmental research and public health 20191220 1

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 b ...[more]

PMID: 31861951

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Project description:BackgroundGuidelines are contradictory regarding the use of alginate in infants with persisting gastroesophageal reflux (GER). While The British National Institute for Health and Care (NICE) guidelines consider alginate as a treatment option, the guidelines of the European and North-American Societies for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN, NASPGHAN) do not recommend alginates.AimsWe assessed the efficacy of alginate to reduce GER episodes in infants.MethodsIn a prospective, observational study, we consecutively enrolled all infants referred for pH-multiple intraluminal impedance (pH-MII) recording because of persisting GER symptoms not responsive to behavior and dietetic modifications. A 48-h pH-MII was performed in all infants; a baseline recording was performed during the first 24 h while magnesium or sodium alginate was administered during the second 24 h. The primary endpoint was the difference in the total number of GER episodes per 24 h between the baseline day and the second day during which the alginate was administered. The secondary outcome was the difference in symptoms between each period. We also compared other pH-MII data from before and during alginate administration.ResultsWe recruited 43 infants (median age 68 days, range 25-306); three pH-MII tracings were excluded because of artifacts. The median number of all MII reflux episodes was significantly reduced during alginate administration (76.0 vs 69.5; p?<?0.001). Crying-fussiness, cough and regurgitation episodes all significantly improved during alginate administration (p = 0.00012; p = 0.005 and p = 0.04, respectively). The following MII parameters also decreased during the alginate administration: acid (19.0 vs 14.5; p?<?0.04), non-acid (52.0 vs 49.5; p?<?0.004), proximal GER episodes (46.0 vs 41.4; p?<?0.007), and bolus exposure index (1.9 vs 1.6; p?=?0.002). At least three out of seven pH-MII parameters decreased by?>?10% during the alginate period in 31/40 infants (77.5%), without a significant difference between magnesium and sodium alginate.ConclusionThese results suggest that alginate significantly decreases the number and extension of both acid and non-acid reflux episodes and associated symptoms in infants.

Dataset Information

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

Publications

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

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