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

Nutrients. 2017 Oct 28;9(11):1181. doi: 10.3390/nu9111181.


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 Lactobacillus reuteri (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%, p < 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, p < 0.0001). Compared to a standard formula, a starch-thickened partially hydrolysed whey protein formula supplemented with Lactobacillus reuteri is more effective in decreasing the frequency of regurgitation and improving GErate, and can be of benefit to infants with FR.

Keywords: Lactobacillus reuteri; gastric emptying; infant formula; partially hydrolysed whey; regurgitation; starch.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Double-Blind Method
  • Gastric Emptying*
  • Humans
  • Infant
  • Infant Formula* / adverse effects
  • Italy
  • Laryngopharyngeal Reflux / diagnostic imaging
  • Laryngopharyngeal Reflux / physiopathology
  • Laryngopharyngeal Reflux / prevention & control*
  • Limosilactobacillus reuteri / physiology*
  • Probiotics / administration & dosage*
  • Probiotics / adverse effects
  • Protein Hydrolysates / administration & dosage*
  • Protein Hydrolysates / adverse effects
  • Starch / administration & dosage*
  • Starch / adverse effects
  • Time Factors
  • Treatment Outcome
  • Whey Proteins / administration & dosage*
  • Whey Proteins / adverse effects


  • Protein Hydrolysates
  • Whey Proteins
  • Starch