Treatment of Gastroesophageal Reflux Disease in Infants

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Change from baseline in reflux episodes in the fourth week of active treatment, compared to placebo — Baseline and daily in 4 weeks.
  Parent-reported reduction in the weekly number of reflux-episodes in the fourth week of active treatment with either PPI or diet, compared to placebo. The outcome is registered daily in an App.

Trial sites (3)

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