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.

Project description:Background & Aims: Because the pathophysiology of GERD is not fully understood, presently used drug target only one or more of the known underlying mechanisms but are not fully effective in all patients. 1Identifying novel central targets may pave the way to develop more effective agents. Methods: A surgical model of sub-chronic reflux esophagitis was developed. Wistar rats were pretreated for 7days with omeprazole (standard proton pump inhibitor) or STW5 (herbal preparation of established efficacy in gastro-intestinal disorders). Treatment was continued for 10days after surgery, rats were sacrificed and esophagi excised. Histological, proteomic and transcriptomic methods were applied to identify reflux induced changes and treatment responses. Results: Protection against reflux induced inflammation was achieved by both test drugs. Both reduced macroscopic and microscopic lesions of the esophagi as well as most measured pro-inflammatory cytokines without significantly affecting NF-kB activity. Proteomic and transcriptomic analysis identified CINC1-3, MIP-1/3Î±, MIG, RANTES and IL-1Î² as highly relevant mediators in GERD. Other highly regulated genes were those of IL-6, CCL3, CCL7 and LOX-1. Many affected cyto-/chemokines were involved in the TREM-1 signaling pathway. The fatty acid receptor GPR84 was highly up-regulated in esophagitis but down-regulated by both drugs. This was confirmed by Western blot and immune-histochemical staining, showing for the first time expression of this receptor in esophageal tissue and its possible involvement in GERD. Conclusion: STW5 and omeprazole target a broad spectrum of molecules involved in immunological and inflammatory processes, of which IL-8 (CINC1-3), TREM-1 pathway and GPR84 are proposed to be most promising novel targets for the treatment of GERD. Refluxesophagitis was surgically induced. Wistar rats were pretreated for 7 days with omeprazole or STW5. Treatment was continued for 10days after surgery, rats were sacrificed and esophagi exiced. The study had 5 groups. Group 1: sham operated, Group 2: esophagitis group, untreated, Group3: esophagitis treated with STW5 0.5ml/kg. Group 4: esophagitis treated with STW5 2ml/kg. Group 5: esophagitis treated with Omeprazole (30mg/kg). 4 microarrays from esophageal tissue and blood from 4 animals of each group were performed.

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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