Background: Guidelines 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.
Aims: We assessed the efficacy of alginate to reduce GER episodes in infants.
Methods: In 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.
Results: We 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.
Conclusion: These results suggest that alginate significantly decreases the number and extension of both acid and non-acid reflux episodes and associated symptoms in infants.