Effects of carob-bean gum thickened formulas on infants' reflux and tolerance indices

AIM: To examine the effect of carob-bean gum(CBG) thickened-formulas on reflux and tolerance indices in infants with gastro-esophageal reflux(GER). METHODS: Fifty-six eligible infants(1-6 mo old) were randomly allocated to receive for two weeks a formula with either 0.33 g/100 m L(Formula A) or 0.45 g/100 m L(Formula B) of cold soluble CBG galactomannans respectively, or a formula with 0.45 g/100 m L of hot soluble CBG galactomannans(Formula C). No control group receiving standard formula was included in the study. Data on the following indices were obtained both at baseline and follow-up from all study participants: 24 h esophageal p H monitoring indices, anthropometrical indices(i.e., body weight and length) and tolerance indices(i.e., frequency of colics; type and frequency ofdefecations). From the eligible infants, forty seven were included in an intention-to-treat analysis to examine the effects of the two-week trial on esophageal 24 h p H monitoring, growth and tolerance indices. Repeated Measures ANOVA was used to examine the research hypothesis.RESULTS: Regarding changes in 24 h p H monitoring indices, significant decreases from baseline to followup were observed in the "Boix Ochoa Score"(i.e., an index of esophageal acid exposure), in the total number of visible refluxes and in all symptoms related indices due to acid reflux only for infants provided with Formula A, while no significant changes were observed for infants provided with Formulas B and C. In addition, the significant decreases observed in two symptoms related p H monitoring indices(i.e., "Symptom index for reflux" and "Percentage of all reflux") for infants provided with Formula A were also found to differentiate significantly compared to the changes observed in the other two groups(P = 0.048 and P = 0.014 respectively). Concerning changes in anthropometric indices, body weight significantly increased among infants provided with Formulas A and C, but not for infants provided with Formula B. As far as tolerance indices were concerned, the numbers of total and diarrheic defecations increased significantly only in infants provided with Formula B and these changes were significantly higher compared to the decreases observed in infants fed with Formulas A and C(P = 0.003 and P = 0.015 respectively. Lastly the number of colics significantly decreased in all infants, irrespective of the tested formula. CONCLUSION: Formula A(i.e., 0.33 g/100 m L of cold galactomannans) was effective in reducing certain p Hmonitoring indices of uncomplicated GER, increased body weight and was well-tolerated by infants.