Gastroesophageal Reflux Clinical Trial
Official title:
Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
The results on the efficacy of the formulations based on alginic acid are controversial. Corvaglia et al demonstrated a significant reduction in reflux episodes in preterm infants by evaluation with pH-impedance analysis. This study concludes that the use of alginic acid reduces the acidity of the gastroesophageal reflux (GER) and has a non-systemic effect and a lesser presence of side effects compared to the use of H2-receptor antagonist(H2RA) and proton pump inhibitor (PPI).
Primary outcomes This prospective, randomized, controlled trial aims to determine, in a
population of infants within one year of life, suffering from gastroesophageal reflux (GER)
the effectiveness of magnesium alginate. The clinical improvement of the patient will be
evaluated based on the negativity of the symptom score (4.3.1), assessed using a validated
questionnaire on symptoms of GER (I-GERQ Annex A).
Secondary outcomes To compare the efficacy of Magnesium Alginate on GER in infants compared
with those of thickened feeding and reassurance, basing on questionnaire results.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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