Treatment of Gastroesophageal Reflux Disease in Infants
Treatment of Gastroesophageal Reflux Disease in Infants- a Randomized Controlled Trial
Odense University Hospital
96 participants
Oct 27, 2025
INTERVENTIONAL
Conditions
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)
Eligibility
Inclusion Criteria5
- Infants diagnosed with gastroesophageal reflux disease (GERD)
- Age \< 1 year at the time of referral
- Age \>1 month at start of treatment
- At least 3 reflux episodes/daily in average
- At least one of following troublesome symptoms are present: Crying of unknown reason, discomfort/irritability, problems gaining weight/ weightloss, rejects the breast or bottle, apnea, back-arching.
Exclusion Criteria8
- Children with diagnosed or suspected syndrome /genetic disorder
- Congenital malformations (minor deformities are excepted)
- Abdominal surgery
- Metabolic disease
- Treatment with proton pump inhibitor within the last week
- Allergy for proton pump inhibitors
- Allergy for cow milk protein
- Infants on Cow's milk free diet
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Interventions
1 mg/kg /day
Mother on cow milk protein diet or infant on hypoallergenic formula in case of bottle fed
Placebo medicine (appearing substantially like Omeprazole) 1mg/ ml, and continuing nutrition containing cows' milk protein
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06255886