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Treatment of Gastroesophageal Reflux Disease in Infants
Sponsor: Odense University Hospital
Summary
Gastroesophageal reflux disease in infants is not fully understood. Infants are prescribed medical treatments that may not be effective or that contribute to adverse side effects and lead to concerns and expenses for the parents and healthcare system. Current guidelines recommend cow-milk-protein free diet as a first-line treatment, but these recommendations are based on weak evidence. This study investigate the efficacy of a cow-milk-protein free diet compared to treatment with a proton pump inhibitor (omeprazole)
Official title: Treatment of Gastroesophageal Reflux Disease in Infants- a Randomized Controlled Trial
Key Details
Gender
All
Age Range
1 Month - 1 Year
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2025-10-27
Completion Date
2026-12-26
Last Updated
2025-11-20
Healthy Volunteers
No
Interventions
Protein pump inhibitor.
1 mg/kg /day
Mother or infant diet
Mother on cow milk protein diet or infant on hypoallergenic formula in case of bottle fed
Placebo
Placebo medicine (appearing substantially like Omeprazole) 1mg/ ml, and continuing nutrition containing cows' milk protein
Locations (3)
Paediatric Department, Hospital of Southern Jutland
Aabenraa, Region Syddanmark, Denmark
Børnelægecentret v/Kasper Dalby
Odense, Region Syddanmark, Denmark
H.C Andersen Childrens' Hospital
Odense, Region Syddanmark, Denmark