Effect of a Partially Hydrolysed Whey Infant Formula Supplemented with Starch and Lactobacillus reuteri DSM 17938 on Regurgitation and Gastric Motility.

Functional regurgitation (FR) is common in early infancy and represents a major drain on healthcare resources. This double-blind, randomized controlled trial investigated the effects of a formula containing partially hydrolysed, 100% whey protein, starch and (DSM 17938) on gastric emptying rate (GErate) and regurgitation frequency in infants with FR. Enrolled infants were randomly allocated to receive either the test formula or a standard starter formula for four weeks. Ultrasound GErate assessment was performed at baseline (week 0) and at week 4; the number of regurgitations, feed volumes and potential adverse events were recorded in a daily diary. Eighty infants aged four weeks to five months were enrolled; 72 (test group = 37; control group = 35) completed the study. Compared to controls, the test group showed greater percentage changes in GErate (12.3% vs. 9.1%, < 0.01). Mean daily regurgitations decreased from 7.4 (0.8) at week 0 to 2.6 (1.0) at week 4 in the test group and from 7.5 (1.0) to 5.3 (1.0) in controls (between-group difference, < 0.0001). Compared to a standard formula, a starch-thickened partially hydrolysed whey protein formula supplemented with is more effective in decreasing the frequency of regurgitation and improving GErate, and can be of benefit to infants with FR.