OBJECTIVES: Anti-regurgitation formulae are recommended in the therapeutic approach of regurgitation. However, their nutritional value needs to be evaluated. It is not known whether the addition of (fibers of) bean gum might influence the intestinal absorption of nutrients and minerals. PATIENTS: Fourty healthy infants were included in an open randomised prospective trial, receiving either a regular adapted (casein/whey ratio 40/60) or an anti-regurgitation (casein/whey ratio 80/20) formula. RESULTS: At the end of the study, at the age of 13 weeks, weight and length gain, and most serum parameters (iron, iron binding capacity, calcium, phosphorus, protein, prealbumin, zinc) were comparable in the 20 infants in each group. The mean intake per day was higher in the anti-regurgitation formula group (755 +/- 55 versus 680 +/- 89 ml/day; p < 0.001), resulting in a higher protein intake (12.80 versus 9.52 g; p < 0.001), which might explain the increased plasma urea level in this group (23.1 versus 15.9 mg/dl; p < 0.001). The albumin level, on the contrary, was smaller in the anti-regurgitation group (4.21 versus 4.85 g/dl; p < 0.001). CONCLUSION: All nutrition parameters are within normal ranges, although there are some significant differences between both groups (for urea and albumin). However, the formula should also be evaluated in therapeutic conditions in regurgitating babies. Differences in intake might be related to the selection of the study population, which were asymptomatic babies.
RCT Entities:
OBJECTIVES: Anti-regurgitation formulae are recommended in the therapeutic approach of regurgitation. However, their nutritional value needs to be evaluated. It is not known whether the addition of (fibers of) bean gum might influence the intestinal absorption of nutrients and minerals. PATIENTS: Fourty healthy infants were included in an open randomised prospective trial, receiving either a regular adapted (casein/whey ratio 40/60) or an anti-regurgitation (casein/whey ratio 80/20) formula. RESULTS: At the end of the study, at the age of 13 weeks, weight and length gain, and most serum parameters (iron, iron binding capacity, calcium, phosphorus, protein, prealbumin, zinc) were comparable in the 20 infants in each group. The mean intake per day was higher in the anti-regurgitation formula group (755 +/- 55 versus 680 +/- 89 ml/day; p < 0.001), resulting in a higher protein intake (12.80 versus 9.52 g; p < 0.001), which might explain the increased plasma urea level in this group (23.1 versus 15.9 mg/dl; p < 0.001). The albumin level, on the contrary, was smaller in the anti-regurgitation group (4.21 versus 4.85 g/dl; p < 0.001). CONCLUSION: All nutrition parameters are within normal ranges, although there are some significant differences between both groups (for urea and albumin). However, the formula should also be evaluated in therapeutic conditions in regurgitating babies. Differences in intake might be related to the selection of the study population, which were asymptomatic babies.