Gastroesophageal Reflux
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTthickened formula
DIETARY_SUPPLEMENTMg alginate
BEHAVIORALreassurance with lifestyle changes
Sponsors
Policlinico Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 1 Years
Healthy volunteers
Yes
Inclusion criteria
* full-term ages 3 to 12 months, affected by symptoms suggestive of GER. * infant regurgitation defined according to the Rome IV criteria * informed consent
Exclusion criteria
* Evidence of chronic diseases, hepatic, renal, or cardiac diseases, metabolic or central nervous system diseases, or use of acid suppressor treatment (H2-receptor antagonists or proton pump inhibitors \[PPIs\]), thickened formula, or a history of prematurity or atopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of symptom scores | From day 0 to day 35 | Infant Gastroesophageal Reflux Questionnaire Revised |
Countries
Italy
Outcome results
None listed