Use of a Partially Hydrolyzed 100% Whey-Based Infant Formula with Lactobacillus Reuteri in Infants with Caregiver-Perceived Intolerance

Abstract

<jats:p>This study evaluated the impact of switching exclusively formula-fed infants with caregiver-perceived formula intolerance to a reduced lactose, partially hydrolyzed 100% whey-based formula (PHF-W) with Lactobacillus reuteri and 2-fucosyllactose. Infants identified as ‘very’ or ‘extremely’ fussy by caregivers were eligible for this single-arm, single-blind study. Subjects switched their current formula to study formula for three weeks. Gastrointestinal tolerance was assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) at baseline and end of the study. Caregivers ranked their infants’ fussiness (not at all, slightly, moderately, very, extremely) after the first three feedings of study formula and 24 hours after enrollment. A paired t-test was used to compare the change in IGSQ score, and a paired t-test and Wilcoxon signed rank test were used to compare post-feeding fussiness scores to baseline. Fifty infants (mean±std age 28.9±14.5 days) were enrolled; 41 completed the study per protocol. Mean (±std) baseline IGSQ score was 34.9±10.0, dropping to 22.1±7.5 after three weeks (p &lt; 0.001). 48/50 (96%) caregivers stated their infants’ fussiness improved after 24 hours, and 2 (4%) remained the same. 42/46 (91%) caregivers stated their infants’ fussiness improved after the first feeding, and 4 (9%) remained the same. Caregiver-ranked fussiness significantly improved after the first, second, and third feedings and after 24 hours as compared to baseline (p &lt; 0.001 for all). IGSQ scores significantly improved after three weeks of feeding with PHF-W containing Lactobacillus reuteri and 2-fucosyllactose in infants with caregiver-perceived intolerance, and improvements in fussiness were noted as quickly as after the first feeding.</jats:p>

Limosilactobacillus reuteri DSM 17938-Containing Infant Formulas and the Associations with Gastrointestinal Tolerance: A Cross-Sectional Observational Study

“…Indeed, the IGSQ composite score in our study for the L. reuteri -containing formula was similar to that from a real-world study for a formula containing L. reuteri and two human milk oligosaccharides reporting scores of 21.3 in mixed-fed infants and 22.7 in exclusively formula-fed infants at approximately 6 weeks of age [ 18 ]. Similarly, infants who switched to a formula containing L. reuteri and 2′fucosyllactose improved their IGSQ composite score from above 30 to 22.1 after receiving the L. reuteri -containing formula for 3 weeks [ 19 ]. Other studies conducted in the US and in China using the IGSQ to assess GI tolerance of formulas with optional ingredients reported lower composite scores [ 20 , 21 ].…”

Safety and efficacy of a probiotic-containing infant formula supplemented with 2’-fucosyllactose: a double-blind randomized controlled trial

“…Infant formulas with 2’FL (0.25 g/L) in combination with Bifidobacterium (B.) lactis Bb12 or Limosilactobacillus (L.) reuteri DSM 17938 (formerly Lactobacillus reuteri DSM 17938) showed good gastrointestinal (GI) tolerance or a potential soothing effect in infants with parent-perceived fussiness, respectively [ 21 , 22 ]. A recent real-world evidence study reported good GI tolerance and age-appropriate growth in infants exclusively fed formula containing 2’FL (1 g/L), LNnT (0.5 g/L) and L. reuteri DSM 17938 or infants who received the formula and breast milk [ 23 ].…”