Treatment of Gastroesophageal Reflux Disease in Infants

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)

NCT Number	NCT06255886
Lead Sponsor	Odense University Hospital
Conditions	Gastroesophageal Reflux, Infant, Newborn, Diseases
Enrollment	96 participants
Start Date	2025-10-27
Primary Completion	2026-12-26 (estimated)
Study Completion	2026-12-26 (estimated)
Updated on ClinicalTrials.gov	2025-11-20