This clinical trial is focused on studying the treatment of Gastroesophageal Reflux Disease (GERD) in infants. GERD is a condition where stomach acid frequently flows back into the tube connecting the mouth and stomach, causing discomfort. The study will also consider infants with a cow’s milk allergy, which is an allergic reaction to proteins found in cow’s milk. The treatment being tested is a medication called Omeprazole, which is a type of drug known as a proton pump inhibitor. This medication is designed to reduce the amount of acid produced in the stomach. The study will compare the effects of Omeprazole with a placebo, which is a substance with no active medication, to see how effective Omeprazole is in treating GERD in infants.

The purpose of the study is to investigate how well a cow’s milk-free diet or Omeprazole works in reducing the symptoms of GERD in infants under one year of age. During the study, parents will be asked to record the number of reflux episodes their child experiences each week using an app. This will help researchers understand how the treatment affects the frequency of reflux episodes. The study will last for several weeks, and parents will be required to monitor and report any changes in their child’s symptoms, such as crying, discomfort, or feeding difficulties.

Throughout the study, the safety and any side effects of Omeprazole will be closely monitored. Parents will report any adverse events, such as stomach pain or nausea, that their child may experience. Additionally, the study will assess changes in the child’s weight and any signs of improvement in symptoms related to GERD and cow’s milk allergy. The trial aims to provide valuable information on the effectiveness of Omeprazole and dietary changes in managing GERD in infants.