Treatment of Gastroesophageal Reflux Disease in Infants
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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