Gastroesophageal Reflux Clinical Trial
A randomized controlled cross-over trial in full-term infants affected by symptoms
suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal
Reflux Questionnaire Revised).
The parents of all of the enrolled infants will be reassured on the benign nature of the
condition and will advise to apply lifestyle changes for one week.
Than, the patients will be randomized into one of the two sequence treatment groups. (group
A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks.
Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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