Dynamics of human milk oligosaccharides in early lactation and relation with growth and appetitive traits of Filipino breastfed infants.

Human milk oligosaccharides play a key role in the maturation of the infant gut microbiome and immune system and are hypothesized to affect growth. This study examined the temporal changes of 24 HMOs and their associations to infant growth and appetitive traits in an exploratory, prospective, observational, study of 41 Filipino mother-infant dyads. Exclusively breastfed, healthy, term infants were enrolled at 21-26 days of age (≈ 0.75 mo) and followed for 6 months. Infant growth measures and appetitive traits were collected at visit 1 (V1) (≈ 0.75 mo), V2 (≈ 1.5 mo), V3 (2.5 mo), V4 (2.75 mo), V5 (4 mo), and V6 (6 mo), while HMOs were measured at V1, V2, V3 and V5. Overall exposure to each HMO was summarized as area under the curve from baseline to 4 months of age and examined in association with each measure of growth at 6 months using linear regression adjusted for maternal age at birth, infant sex, birth weight, and mode of delivery. We saw modest associations between several HMOs and infant growth parameters. Our results suggest that specific HMOs, partly as proxy for milk groups (defined by Secretor and Lewis status), may be associated with head circumference and length, increasing their relevance especially in populations at the lower end of the WHO growth curve. We did not identify the same HMOs associated with infant appetitive traits, indicating that at least in our cohort, changes in appetite were not driving the observed associations between HMOs and growth.Clinical trial registration: NCT03387124.

Clinical Response to Two Formulas in Infants with Parent-Reported Signs of Formula Intolerance: A Multi-Country, Double-Blind, Randomized Trial.

BACKGROUND: Signs of feeding intolerance are common in formula-fed infants. We evaluated the clinical response to a partially hydrolyzed 100% whey protein formula with high sn-2 palmitate and reduced lactose (FA) and to an alpha-lactalbumin-enriched whey-predominant intact protein formula with full lactose (FB) in healthy full-term infants with parent-reported signs of feeding intolerance. METHODS: In a double-blind, parallel-group trial in 6 Asian study centers, exclusively formula-fed infants aged 30 to 90 days, whose parents reported fussiness-crying for ≥2 hours/day plus gassiness and/or stooling difficulty, and intended to switch formula, were randomly assigned to FA (n = 130) or FB (n = 129) for 14 days. Primary endpoint was daily duration of fussiness-crying. Secondary endpoints included gassiness, spitting-up, vomiting, sleep pattern, Infant Gastrointestinal Symptom Questionnaire (IGSQ) Index, infant temperament and maternal anxiety. RESULTS: Mean ± SE minutes/day of fussiness-crying in the 256 analyzed infants (FA, n = 127 and FB, n = 129) substantially decreased from baseline to study end in FA (291 ± 14 to 140 ± 8; -52%, P < .001), and FB (313 ± 14 to 153 ± 11, -51%, P < .001) with no difference between groups. Similarly, gassiness, spitting-up, vomiting and sleep pattern significantly improved by study end for both formulas. Mean ± SE IGSQ index scores significantly decreased from baseline to study end (FA: 44.5 ± 0.9 to 28.6 ± 0.7; FB: 44.5 ± 0.8 to 29.0 ± 0.7; P < .001) with no differences between groups. Infant temperament and maternal anxiety also improved significantly in both groups by study end. CONCLUSION: Switching from standard, full-lactose, intact whey/casein infant formulas to either study formula resulted in an improvement of gastrointestinal symptoms and associated behaviors in infants with signs of feeding intolerance. TRIAL REGISTRATION: https://clinicaltrials.gov, NCT02021058.

Health-related quality of life, temperament, and eating behavior among formula-fed infants in the Philippines: a pilot study.

BACKGROUND: The rising prevalence of childhood obesity in Asia has led to interest in potential risk factors such as infant health-related quality of life (HRQoL), temperament and eating behaviors. This pilot study evaluated the utility of administering parent-reported outcome measures (PROMs) to explore these factors in Filipino infants and examined the relationships between these factors and infant sex, formula intake and weight, over time. METHODS: Forty healthy, 4-week-old, formula-fed infants (n = 20 males) were enrolled in this 6-week, prospective, uncontrolled study during which infants were exclusively fed a standard term infant formula enriched with alpha-lactalbumin. On Day-1 and 42, anthropometrics were measured and mothers completed a 97-item measure of HRQoL [Infant Toddler Quality of Life Questionnaire (ITQOL)] covering 6 infant-focused and 3 parent-focused concepts and a 24-item measure of infant temperament [Infant Characteristics Questionnaire (ICQ)]. At Day-42, mothers also completed an 18-item measure of infant appetite [Baby Eating Behaviour Questionnaire (BEBQ)]. A 3-day formula intake diary was completed before Day-42. Nonparametric statistics were used to evaluate correlations among outcomes and compare outcomes by visit and sex. RESULTS: Thirty-nine infants completed the study; similar results were observed in males and females. Completion of PROMs was 100% with no missing responses, but Cronbach's α was low for many concept scales scores. ITQOL scores [range 0 (worst)-100 (best)] were generally high (median ≥ 80) except for Day-1 and Day-42 Temperament and Mood and Day-1 General Health Perceptions scores. ITQOL but not ICQ temperament scores improved significantly between Day-1 and Day-42 (P < 0.01). Mean ± standard deviation BEBQ scores (range 1-5) were high for Enjoyment of Food (4.59 ± 0.60) and Food Responsiveness (3.53 ± 0.81), and low for Satiety Responsiveness (2.50 ± 0.73) and Slowness in Eating (1.71 ± 0.60). Better HRQoL scores were significantly (P < 0.05) associated with high General Appetite scores (3 ITQOL concepts, r = 0.32 to 0.54), greater Enjoyment of Food (4 ITQOL concepts, r = 0.35 to 0.42) and low levels of Slowness in Eating (7 ITQOL concepts, r = - 0.32 to - 0.47). CONCLUSION: Findings demonstrated the utility of the ITQOL, ICQ and BEBQ for measuring HRQoL, temperament and eating behavior, and the need for further adaptations for use in Filipino infants. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02431377; Registered May 1, 2015.

Effects of term infant formulas containing high sn-2 palmitate with and without oligofructose on stool composition, stool characteristics, and bifidogenicity.

OBJECTIVES: Levels of stool fatty acid soaps and beneficial bacteria differ between formula-fed and breast-fed infants; addition of specific formula ingredients may reduce these differences. This study evaluated the effects of a term infant formula containing high sn-2 palmitate term infant formula (sn-2) or an identical formula supplemented with oligofructose (OF) at 2 concentrations (sn-2+3 g/L OF, sn-2+5 g/L OF) on stool composition, stool characteristics, and fecal bifidobacteria. METHODS: Healthy, term formula-fed infants 7 to 14 days old (n = 300) were randomized in a double-blind manner to receive standard formula (control), sn-2, sn-2+3 g/L OF, or sn-2+5 g/L OF for 8 weeks. Human milk (HM)-fed infants (n = 75) were studied in parallel. Stool samples were collected from all subjects at week 8 for fatty acid soaps and mineral content, and from a subset at baseline and week 8 for bifidobacteria. Stool characteristics were assessed via 3-day diary. RESULTS: The sn-2 group had 46% less stool soap palmitate (P < 0.001) and softer stools than control (20% more mushy soft stools, P = 0.026; 50% fewer formed stools, P = 0.003). Addition of OF resulted in even fewer formed stools versus control (65% fewer for sn-2+3 g/L OF, 79% fewer for sn-2+5 g/L OF), with 5 g/L OF more closely resembling that of HM-fed infants. Both sn-2 (P < 0.05) and sn-2 with OF groups (P < 0.01) had significantly higher fecal bifidobacteria concentrations than control at week 8, not differing from HM-fed infants. CONCLUSIONS: High sn-2-palmitate formulas led to reduced stool soaps, softer stools, and increased bifidobacteria, whereas addition of OF further improved stool consistency. Those modifications brought outcomes in formula-fed infants closer to that in HM-fed infants.

Lutein-fortified infant formula fed to healthy term infants: evaluation of growth effects and safety.

BACKGROUND/OBJECTIVES: Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification. SUBJECTS/METHODS: This 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold+Lutein). Two hundred thirty-two (232) infants