NCT06255886View on ClinicalTrials.gov

Treatment of Gastroesophageal Reflux Disease in Infants

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

October 1, 2026

Study Completion Date

October 1, 2026

Conditions
Gastroesophageal RefluxInfant, Newborn, Diseases
Interventions
DRUG

Protein pump inhibitor.

1 mg/kg /day

BEHAVIORAL

Mother or infant diet

Mother on cow milk protein diet or infant on hypoallergenic formula in case of bottle fed

DRUG

Placebo

Placebo medicine (appearing substantially like Omeprazole) 1mg/ ml, and continuing nutrition containing cows' milk protein

All Listed Sponsors
lead

Odense University Hospital

OTHER