Treatment of Gastroesophageal Reflux Disease in Infants

An increasing number of infants less than one year of age have been referred to the pediatric departments with gastroesophageal reflux in the past decade. Gastroesophageal reflux is a common condition in infants defined as the passage of gastric contents into the esophagus with regurgitation or vomiting. Around 50% of infants younger than four months regurgitate or vomit regularly. In most cases, it is a harmless, self-limiting condition; in 90% of cases, the symptoms diminish before 12 months. However, if reflux leads to troublesome symptoms or complications, it is defined as gastroesophageal reflux disease. Troublesome symptoms may include failure to thrive, back arching, food refusal, regurgitation, and irritability. The prevalence of gastroesophageal reflux disease varies between studies. Infants can be treated medically, and proton pump Inhibitors have been recommended as the first choice. However, within the last few years, there has been concern among pediatricians that too many infants are unnecessarily treated with this medication. There are only a few randomized studies on proton pump inhibitor treatment in children under one year, and most studies do not show a significant effect on symptoms. Side effects of treatment with proton pump inhibitors include symptoms related to the gastrointestinal tract or airways, increased susceptibility to infections, and increased risk of developing allergy later in life. Within the past years, there has been attention to the overlapping of symptoms between gastroesophageal reflux disease and allergy to cow milk protein. Cow-milk-protein allergy is the most common food allergy in early childhood, with an estimated prevalence of 2-3%, and presents with various symptoms predominantly from the skin and gastrointestinal tract. Consequently, cow-milk-protein allergy can be challenging to differentiate from gastroesophageal reflux disease. Cow-milk-protein-allergy is an immune reaction and can be either immunoglobulin E-mediated, presenting with immediate reaction including anaphylaxis, or non-immunoglobulin E-mediated, presenting with delayed symptoms. In addition, it is possible that cow's milk can aggravate gastroesophageal reflux disease with a non-immunologic mechanism. As there is no biomarker to differentiate non-immunoglobulin E-mediated cow-milk allergy from gastroesophageal reflux disease, the diagnosis of non-immunoglobulin E-mediated cow-milk allergy can only be verified by an oral food challenge test preceded by a cow-milk-protein-elimination period. Therefore, in the updated international guidelines, all children with gastroesophageal reflux disease should start with a 2-4-week cow-milk-protein-elimination diet before a proton pump inhibitor is prescribed. However, evidence is scarce on the effect of a cow-milk-protein-free diet in infants diagnosed with gastroesophageal reflux disease.

• Change from baseline in reflux episodes in the fourth week in the PPI group, compared to the diet group. [Срок оценки: Baseline and 4 weeks]
• Change from baseline in weight [Срок оценки: Baseline and 4 weeks]
• Change from baseline in the number of reflux episodes with visible blood [Срок оценки: 1,2,3,4 weeks]
• Change from baseline in the number of episodes with discomfort [Срок оценки: 1,2,3,4 weeks]
• Change from baseline in the numbers of episodes with crying [Срок оценки: 1,2,3,4 weeks]
• Change from baseline in the number of episodes of refusing breast/ bottle [Срок оценки: 1,2,3,4 weeks]
• Change from baseline in the number of episodes with short breathing pauses [Срок оценки: 1,2,3,4 weeks]
• Change from baseline in the number of episodes with paleness/blue color in face or lips [Срок оценки: 1,2,3,4 weeks]
• Change from baseline in the number of episodes with troublesome breathing/cough [Срок оценки: 1,2,3,4 weeks]
• Immunoglobulin E level [Срок оценки: 4 weeks after treatment is started]