BACKGROUND: Thickened milk formulas are used to treat infants with gastroesophageal reflux (GER), but these substances often increase the duration of reflux episodes and worsen symptoms, and they have been associated with diarrhea, constipation, and cough. OBJECTIVES: The aims of this study were to determine the efficacy of an antiregurgitation milk formula in the clinical and laboratory setting in infants with proved GER, to investigate any possible adverse events (cough and change in the number of bowel movements or the consistency of stools), and to identify its effects on height and body weight. METHODS:Infants with recurrent vomiting and GER who were not responsive to standard treatment were eligible for the study. Infants in the treatment group (group A) were managed for 4 weeks with a specific antiregurgitation milk formula (with cornstarch and an increased amount of casein), and those in the control group (group B) were given a standard milk formula. The number of episodes of vomiting, regurgitation, and cough, as well as the frequency and consistency of stool, height, and body weight were noted at least 10 days before and during the study. A second pH monitoring was performed after 4 weeks in both groups. RESULTS:Fifty-six infants (30 boys, 26 girls; mean [SD] age, 3.1 [1.2] months) were included in the study; 30.4% had mild GER; 44.6%, moderate GER; and 25.0%, severe GER. Significantly more infants in group A than in group B (50.0% vs 14.3%, respectively) with mild or moderate GER had normal findings on the second pH monitoring (P<0.05). Changes in the reflux index and in the mean number of vomiting and regurgitation episodes were significantly different between the 2 groups (P<0.05). No significant differences in changes in the mean number of bowel movements and cough events or in the consumption time of the 2 formulas were found between the 2 groups. CONCLUSION:Infants with mild or moderate GER can be managed effectively with this antiregurgitation milk formula. Improved clinical and laboratory findings were seen in the majority of infants, and the formula was well tolerated, without adverse events.
RCT Entities:
BACKGROUND: Thickened milk formulas are used to treat infants with gastroesophageal reflux (GER), but these substances often increase the duration of reflux episodes and worsen symptoms, and they have been associated with diarrhea, constipation, and cough. OBJECTIVES: The aims of this study were to determine the efficacy of an antiregurgitation milk formula in the clinical and laboratory setting in infants with proved GER, to investigate any possible adverse events (cough and change in the number of bowel movements or the consistency of stools), and to identify its effects on height and body weight. METHODS:Infants with recurrent vomiting and GER who were not responsive to standard treatment were eligible for the study. Infants in the treatment group (group A) were managed for 4 weeks with a specific antiregurgitation milk formula (with cornstarch and an increased amount of casein), and those in the control group (group B) were given a standard milk formula. The number of episodes of vomiting, regurgitation, and cough, as well as the frequency and consistency of stool, height, and body weight were noted at least 10 days before and during the study. A second pH monitoring was performed after 4 weeks in both groups. RESULTS: Fifty-six infants (30 boys, 26 girls; mean [SD] age, 3.1 [1.2] months) were included in the study; 30.4% had mild GER; 44.6%, moderate GER; and 25.0%, severe GER. Significantly more infants in group A than in group B (50.0% vs 14.3%, respectively) with mild or moderate GER had normal findings on the second pH monitoring (P<0.05). Changes in the reflux index and in the mean number of vomiting and regurgitation episodes were significantly different between the 2 groups (P<0.05). No significant differences in changes in the mean number of bowel movements and cough events or in the consumption time of the 2 formulas were found between the 2 groups. CONCLUSION:Infants with mild or moderate GER can be managed effectively with this antiregurgitation milk formula. Improved clinical and laboratory findings were seen in the majority of infants, and the formula was well tolerated, without adverse events.