Cow Milk-based Infant Formula Research Articles

Plasma Sphingomyelins and Carnitine Esters of Infants Consuming Whole Goat or Cow Milk-Based Infant Formulas or Human Milk

BackgroundInfant formulas are typically manufactured using skimmed milk, whey proteins, and vegetable oils, which excludes milk fat globule membranes (MFGM). MFGM contains polar lipids, including sphingomyelin (SM). ObjectiveThe objective of this study was comparison of infant plasma SM and acylcarnitine species between infants who are breastfed or receiving infant formulas with different fat sources. MethodsIn this explorative study, we focused on SM and acylcarnitine species concentrations measured in plasma samples from the TIGGA study (ACTRN12608000047392), where infants were randomly assigned to receive either a cow milk-based infant formula (CIF) with vegetable oils only or a goat milk-based infant formula (GIF) with a goat milk fat (including MFGM) and vegetable oil mixture to the age ≥4 mo. Breastfed infants were followed as a reference group. Using tandem mass spectrometry, SM species in the study formulas and SM and acylcarnitine species in plasma samples collected at the age of 4 mo were analyzed. ResultsTotal SM concentrations (∼42 μmol/L) and patterns of SM species were similar in both formulas. The total plasma SM concentrations were not different between the formula groups but were 15 % (CIF) and 21% (GIF) lower in the formula groups than in the breastfed group. Between the formula groups, differences in SM species were statistically significant but small. Total carnitine and major (acyl) carnitine species were not different between the groups. ConclusionsThe higher total SM concentration in breastfed than in formula-fed infants might be related to a higher SM content in human milk, differences in cholesterol metabolism, dietary fatty acid intake, or other factors not yet identified. SM and acylcarnitine species composition in plasma is not closely related to the formula fatty acid composition.This trial was registered at Australian New Zealand Clinical Trials Registry as ACTRN12608000047392

Cow's milk-based infant formula supplements in breastfed infants and primary prevention of cow's milk allergy: A commentary of the Committee on Nutrition of the French Society of Pediatrics

The role of nutritional interventions for the primary prevention of cow's milk allergy (CMA) remains debated as well as the role of early introduction of allergenic foods, which is largely encouraged from the beginning of complementary feeding. Considering the introduction of cow's milk protein (CMP), current recommendations suggest avoidance of any cow's milk formula (CMF) supplements in breastfed infants in the maternity ward. By contrast, based on poor evidence, some authors support systematic supplements of CMP in breastfed children at risk of allergy from the first week of life. The Committee on Nutrition of the French Society of Pediatrics considers that such a proposal requires more clinical studies and mainly randomized and placebo-controlled clinical trials before becoming a recommendation.

Comparison of phospholipid composition and microstructure of milk fat globules contained in human milk and infant formulae.

Phospholipids play key roles in infant nutrition and cognitive development. It is hypothesized that infant formula (IF) has lower phospholipid species, content and milk fat globule (MFG) structural integrity than human milk (HM). Herein, we performed qualitative and quantitative analyses of phospholipids in six classes of IF and HM using ultra-performance liquid chromatography with mass spectrometry. The contents of phosphatidylethanolamine (15.81±7.20mg/L) and sphingomyelin (35.84±15.56mg/L) in IF were significantly lower than those in HM (30.74±17.38mg/L, 45.53±16.04mg/L, respectively). Among the six IF classes, cow's milk-based IF had the highest number of phospholipid species, and IF containing milk fat globular membrane had the highest phospholipid content. The size, zeta potential, and amount of MFGs in IF were significantly lower than those in HM. These results may prove useful for designing better IF that mimic HM.

Improved Neurodevelopmental Outcomes at 5.5 Years of Age in Children Who Received Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula Through 12 Months: A Randomized Controlled Trial

To evaluate neurodevelopmental outcomes at 5.5 years of age in children who were previously randomized to cow milk-based infant formula (control) or similar formula (milk fat globule membrane plus lactoferrin [MFGM+LF]) with added sources of bovine MFGM and bovine LF (bLF) through 12 months of age. Children who completed study feeding were invited to participate in follow-up assessments: cognitive development across multiple domains (primary outcome; Wechsler Preschool & Primary Scale of Intelligence™, 4th Edition; WPPSI™-IV), inhibitory control/rule learning (Stroop Task), flexibility/rule learning (Dimensional Change Card Sort; DCCS), and behavior/emotion (Child Behavior Checklist; CBCL). Of 292 eligible participants (Control: 148, MFGM+LF: 144), 116 enrolled and completed assessments (Control: 59, MFGM+LF: 57). There were no group demographic differences except family income (MFGM+LF significantly higher). WPPSI-IV composite scores (mean±SE) for Visual Spatial (100.6±1.7 vs 95.3±1.7; P=0.027), Processing Speed (107.1±1.4 vs 100.0±1.4; P<0.001), and Full Scale IQ (98.7±1.4 vs 93.5±1.5; P=0.012) were significantly higher for MFGM+LF vs Control, even after controlling for demographic/socioeconomic factors. Stroop Task scores were significantly higher in MFGM+LF vs control (P<0.001). Higher DCCS scores (P=0.013) in the border phase (most complex/challenging) were detected and more children passed the border phase (32% vs 12%; P=0.039) for MFGM vs control. No group differences in CBCL score were detected. Children who received infant formula to 12 months of age with added bMFGM and bLF vs standard formula demonstrated improved cognitive outcomes in multiple domains at 5.5 years of age, including measures of intelligence and executive function.

Elucidating gut microbiota and metabolite patterns shaped by goat milk-based infant formula feeding in mice colonized by healthy infant feces

The gut microbiota plays an evolutionarily conserved role in host metabolism, which is influenced by diet. Here, we investigated differences in shaping the gut microbiota and regulating metabolism in cow milk-based infant formula, goat milk-based infant formula, and mix milk-based infant formula compared with pasteurized human milk. 16S rRNA results showed that goat milk-based infant formula selectively increased the relative abundance of Blautia, Roseburia, Alistites and Muribaculum in the gut compared to other infant formulas. Metabolomics identification indicated that goat milk-based infant formula mainly emphasized bile acid biosynthesis, arachidonic acid metabolism and steroid biosynthesis metabolic pathways. Metabolites associated with these metabolic pathways were positively associated with increased microorganisms in goat milk-based infant formula, particularly Alistipes. Furthermore, we found a deficiency of Akkermansia abundance in three infant formula-fed compared to pasteurizedhuman milk-fed. This study presents new insights into the improvement and application of goat milk-based infant formulas in terms of intestinal microecology.

NOVEL PLANT-BASED PEDIATRIC FORMULA ALTERNATIVE FOR MANAGEMENT OF NON-IGE-MEDIATED FOOD ALLERGIES: A CASE STUDY

<h3>Introduction</h3> Traditional management of food protein-induced allergic proctocolitis (FPIAP) includes use of extensively hydrolyzed or elemental formula and/or the removal of dairy and soy from maternal diet for breastmilk-fed infants. This case outlines use of a novel plant-based pediatric formula in an infant diagnosed with dairy and soy-protein FPIAP. <h3>Case Description</h3> At 2 weeks of age, P presented with a dusky, distended belly and stridor within 24 hours of initial exposure to a polymeric cow milk-based infant formula. Following standard protocol for suspected FPIAP, he was transitioned to an elemental formula and his mother was placed on an elimination diet. Breastmilk was re-introduced after 10 days of elimination diet with formula supplementation. He was transitioned to supplemental extensively-hydrolyzed casein formula at 6 months. At age 10 months, due to U.S. infant formula shortages, P transitioned successfully to a novel plant-based pediatric formula sourced from almonds and buckwheat that is free of soy, rice, and pea proteins. P failed cow's milk challenge and subsequently pea-protein milk challenge upon turning 12 months, which both induced repeated gastrointestinal distress. Symptoms resolved upon re-introduction of the novel plant-based formula. <h3>Discussion</h3> This case demonstrates that an alternative protein-sourced formula has the potential to serve as a safe alternative therapy strategy to address patients with FPIAP unable to exclusively breastfeed and/or tolerate traditional formulas. These findings justify the need for further development and demonstration in a clinical setting of an alternative protein-sourced infant formula to be used in the standard management of food allergy disorders.

Alternatives to Cow's Milk-Based Infant Formulas in the Prevention and Management of Cow's Milk Allergy.

Cow’s milk-based infant formulas are the most common substitute to mother’s milk in infancy when breastfeeding is impossible or insufficient, as cow’s milk is a globally available source of mammalian proteins with high nutritional value. However, cow’s milk allergy (CMA) is the most prevalent type of food allergy among infants, affecting up to 3.8% of small children. Hypoallergenic infant formulas based on hydrolysed cow’s milk proteins are commercially available for the management of CMA. Yet, there is a growing demand for more options for infant feeding, both in general but especially for the prevention and management of CMA. Milk from other mammalian sources than the cow, such as goat, sheep, camel, donkey, and horse, has received some attention in the last decade due to the different protein composition profile and protein amino acid sequences, resulting in a potentially low cross-reactivity with cow’s milk proteins. Recently, proteins from plant sources, such as potato, lentil, chickpeas, quinoa, in addition to soy and rice, have gained increased interest due to their climate friendly and vegan status as well as potential lower allergenicity. In this review, we provide an overview of current and potential future infant formulas and their relevance in CMA prevention and management.

Elucidating the physicochemical properties and surface composition of goat milk-based infant formula powders

This study investigated the characteristics of cow milk-based, goat milk-based, and mixed-based (using goat milk and cow whey powder)infant formulas (IF) with different sources of casein and whey protein, aiming to construct the properties of powders prepared using goat milk. Goat milk-based IF have different water activity, color, and glass transition temperature than other IF, whereas the crystallinity and solubility were similar. SDS-PAGE pattern showed that goat milk-based and mixed-based IF contained higher β-casein, while cow milk-based IF contained higher αs1-casein. The differentials of casein affected the powder surface composition and free fat levels. Goat milk-based IF reduces the surface fat content and free fat levels of the particles. Further analysis showed that the surface of the particles was predominantly filled with saturated fatty acids. Our findings revealed that due to the different casein, goat milk-based IF have favorable characteristics and surface composition, thus promoting its particle stability.

Analysis of the Endogenous Peptidomes of Different Infant Formula Types and Human Milk.

Infant formula (IF) is a commonly used replacement whenever mother’s own milk is not available. Most IFs are based on cow milk (powders, liquids). Alternatives, based on other sources such as goat milk or plants, exist. Independent of the source, IF production and composition are strictly regulated. Besides proteins, minerals, and lipids, milk contains a variety of endogenous peptides. Whereas the human milk peptidome has been studied intensively, the peptidomes of IFs have been mostly neglected. This study investigated the peptidomes of different types of first stage IF, including cow milk-based powders and liquids, and powdered goat milk-based IF, highlighting major similarities and differences to human milk. Extracted native peptidomes were analyzed by nanoRPC-ESI-MS/MS using two different fragmentation techniques allowing the confident identification of 1587 peptides. β-Casein peptides dominated in all samples. Interestingly, powdered and liquid cow milk-based IFs differed in the numbers of β- and αS1-casein peptides, indicating processing-derived variations. However, the peptidomes of cow and goat milk-based IF appeared to be more comparable to each other than to human milk. Despite an overlap in the major source proteins, many peptide sequences were different, i.e., species-specific. Remarkably, the data indicate that the human milk peptidome might be donor-specific as well.

Dietary compliance in a randomized double-blind infant feeding trial during infancy aiming at prevention of type 1 diabetes.

The international Trial to Reduce IDDM in the Genetically at Risk (TRIGR) tested the hypothesis whether extensively hydrolyzed casein‐based versus regular cow's milk‐based infant formula reduces the risk of type 1 diabetes. We describe dietary compliance in the trial in terms of study formula intake, feeding of nonrecommended foods, and serum cow's milk antibody concentration reflecting intake of cow's milk protein among 2,159 eligible newborn infants with a biological first‐degree relative affected by type 1 diabetes and with HLA‐conferred susceptibility to type 1 diabetes. The participating infants were introduced to the study formula feeding at the median age of 15 days with a median duration of study formula use of 63 days. During the intervention, 80% of the infants received study formula. Of these, 57% received study formula for at least 2 months. On average, 45.5 l of study formula were used per infant. Only 13% of the population had received a nonrecommended food by the age of 6 months. The dietary compliance was similar in the intervention and control arm. The reported cow's milk consumption by the families matched very well with measured serum casein IgA and IgG antibody concentration. To conclude, good compliance was observed in this randomized infant feeding trial. Compliance varied between the regions and those infants who were breastfed for a longer period of time had a shorter exposure to the study formula. High dietary compliance in infant feeding trial is necessary to allow accurate interpretation of study results.

EAACI guideline: Preventing the development of food allergy in infants and young children (2020 update).

This guideline from the European Academy of Allergy and Clinical Immunology (EAACI) recommends approaches to prevent the development of immediate-onset / IgE-mediated food allergy in infants and young children. It is an update of a 2014 EAACI guideline. The guideline was developed using the AGREE II framework and the GRADE approach. An international Task Force with representatives from 11 countries and different disciplinary and clinical backgrounds systematically reviewed research and considered expert opinion. Recommendations were created by weighing up benefits and harms, considering the certainty of evidence and examining values, preferences and resource implications. The guideline was peer-reviewed by external experts, and feedback was incorporated from public consultation. All of the recommendations about preventing food allergy relate to infants (up to 1year) and young children (up to 5years), regardless of risk of allergy. There was insufficient evidence about preventing food allergy in other age groups. The EAACI Task Force suggests avoiding the use of regular cow's milk formula as supplementary feed for breastfed infants in the first week of life. The EAACI Task Force suggests introducing well-cooked, but not raw egg or uncooked pasteurized, egg into the infant diet as part of complementary feeding. In populations where there is a high prevalence of peanut allergy, the EAACI Task Force suggests introducing peanuts in an age-appropriate form as part of complementary feeding. According to the studies, it appears that the most effective age to introduce egg and peanut is from four to 6months of life. The EAACI Task Force suggests against the following for preventing food allergy: (i) avoiding dietary food allergens during pregnancy or breastfeeding; and (ii) using soy protein formula in the first 6months of life as a means of preventing food allergy. There is no recommendation for or against the following: use of vitamin supplements, fish oil, prebiotics, probiotics or synbiotics in pregnancy, when breastfeeding or in infancy; altering the duration of exclusive breastfeeding; and hydrolysed infant formulas, regular cow's milk-based infant formula after a week of age or use of emollients. Key changes from the 2014 guideline include suggesting (i) the introduction of peanut and well-cooked egg as part of complementary feeding (moderate certainty of evidence) and (ii) avoiding supplementation with regular cow's milk formula in the first week of life (low certainty of evidence). There remains uncertainty in how to prevent food allergy, and further well-powered, multinational research using robust diagnostic criteria is needed.

Effect of extensively hydrolyzed casein vs. conventional formula on the risk of asthma and allergies: The TRIGR randomized clinical trial

The role of hydrolyzed infant formulas in the prevention of asthma and allergies remains inconsistent. We tested whether extensively hydrolyzed casein formula compared to conventional cow's milk-based formula prevented asthma, allergic rhinitis, or atopic eczema. In the randomized double-blind Trial to Reduce IDDM in Genetically at Risk (TRIGR), comparing extensively hydrolyzed to standard cow's milk-based infant formula during the first 6-8months of life, we assessed the effect of the intervention on the incidence of asthma, allergic rhinitis, and eczema when the children were 9- to 11-years old. The asthma, allergic rhinitis, and eczema occurrence was assessed using online standardized and validated ISAAC questionnaire. Of the 1106 children who participated in this Ancillary study, 560 had been randomized to the experimental (extensively hydrolyzed casein formula) and 546 to the control arm (cow's milk-based formula). The risk of persistent asthma, allergic rhinitis, or atopic eczema did not differ by treatment, the hazard ratios (95% CI) being 1.00 (0.66-1.52), 0.95 (0.66-1.38), and 0.89 (0.70-1.15), respectively, in the intention-to-treat analysis. Neither were there any differences in the per-protocol analysis. Extensively hydrolyzed casein formula did not protect from asthma, rhinitis, or eczema in this population carrying genetic risk for type 1 diabetes.

Comparison of the Bifidogenic Effects of Goat and Cow Milk-Based Infant Formulas to Human Breast Milk in an in vitro Gut Model for 3-Month-Old Infants.

Human milk contains prebiotic components, such as human milk oligosaccharides (HMOs), which stimulate the growth of specific members of the infant gut microbiota (e.g., Bifidobacteria). Plant-based or synthetic oligosaccharides are often added to infant formulas to simulate the bifidogenic effect of HMOs. Cow milk, the most common source of protein in infant formula, and goat milk, used increasingly in the manufacture of infant formula, contain naturally-occurring prebiotics. This study compared the upper gastrointestinal digestion and subsequent colonic fermentation of human milk vs. goat and cow milk-based infant formulas (goat IF and cow IF, respectively), without additional oligosaccharides using an in vitro model for 3-month-old infants based on the Simulator of the Human Intestinal Microbial Ecosystem (SHIME®). First, a dialysis approach using 3.5 kDa membranes was demonstrated to simulate small intestinal absorption of carbohydrates in conditions similar to those in vivo. During the in vitro digestion experiment, oligosaccharides were detected in human milk and goat IF but barely detected in the cow IF. Further, all three milk matrices decreased colonic pH by boosting acetate, lactate, and propionate production, which related to increased abundances of acetate/lactate-producing Bifidobacteriaceae for human milk (+25.7%) and especially goat IF (33.8%) and cow IF (37.7%). Only cow IF stimulated butyrate production which correlated with an increase in Lachnospiraceae and Clostridiaceae. Finally, Enterobacteriaceae and Acidaminococcaceae also increased with all three milk matrices, while production of proteolytic metabolites (branched-chain fatty acids) was only detected for the cow IF. Overall, goat and cow milk-based formulas without added oligosaccharides impacted gut microbial activity and composition similarly to human milk. This suggests that even without supplementation of formula with oligosaccharides, whole goat milk, whole cow milk and cow milk ingredients already supply compounds in formulas that exert beneficial bifidogenic effects. Further clinical research is warranted to elucidate the effect of whole goat milk-based formulas on the infant gut microbiome.

Peptide array-based inhibition ELISA for evaluating antigenicity in infant formulas

With increased awareness among consumers regarding food safety and security, food allergen control has become an indispensable requirement in the food industry. Although several methods for detecting allergens in food products are available, highly sensitive techniques are required. In this study, we developed a technique named as peptide array-based inhibition enzyme-linked immunosorbent assay (ELISA), Pep-iEIA, for evaluating antigenicity and detecting cow's milk antigen in infant formula products, using a peptide array consisting of a series of overlapping peptides found in allergenic milk proteins. Pep-iEIA was used to examine five cow's milk-based infant formulas with different degrees of hydrolyzation, and the assay offered both more sensitive detection and detailed analysis of remaining antigenic peptides in allergen compared to conventional ELISA. The antigenicity level of the allergenic peptides identified using Pep-iEIA was confirmed by surface plasmon resonance assay. We believe that Pep-iEIA will be highly useful for antigenicity evaluation of dairy products consumed by infants and patients with cow's milk allergy.

Growth Through 24 Months of Age in Infants Receiving Formulas with or Without Added Bovine Milk Fat Globule Membrane (MFGM) or Human Milk Through the First Year of Life: An RCT

Abstract Objectives To evaluate growth through 24 months of age in infants receiving added bovine milk fat globule membrane (MFGM) in infant formula through 12 months of age. Concentration of MFGM from bovine milk fractions and incorporation in infant formula may better approximate the composition of complex milk lipids in human milk. Methods In the double-blind, randomized, controlled Chilean Infant Nutrition Trial (ChiNuT; NCT0262613), term infants whose mothers chose to initiate exclusive infant formula feeding before 4 months of age were randomized to receive: a standard cow's milk-based infant formula (SF, n = 174) or a similar formula with added whey protein-lipid concentrate (5 g/L; source of bovine MFGM) (bMFGM, n = 176). A reference group of infants exclusively receiving human milk (HM, n = 236) was also recruited. Growth through 24 months of age was the primary outcome. Length-for-age (LAZ), weight-for-age (WAZ) and body mass index (BMI)-for-age (BAZ) growth z-scores were analyzed by mixed-effects multiple linear regression models adjusted by sex, age (days), and maternal pregestational BMI (kg/m2). Results No significant group differences in sex, gestational age at birth, birthweight, maternal age and maternal education were detected, with the exception of maternal pregestational BMI (mean(SD)) (HM: 27.0(5.2) lower vs SF: 28.6(6.2) or bMFGM: 28.9(6.1); P = 0.002). Groups were similar at baseline (weight, length, WAZ, BAZ) with the exception of LAZ (lower in the bMFGM compared to HM group; P &amp;lt; 0.05). No significant differences in growth z-scores (absolute at 6, 9, 12, and 24 months of age or change between baseline and each study time point) were detected between SF and MFGM groups. Both randomized study formula groups were associated with higher growth z-score increases from baseline compared to the HM reference group between 6 and 24 months (P less than 0.05). Mean growth z-scores fell within the range of −1 to 1 (16th to 84th percentile) for SF, bMFGM, and HM groups at all study time points. Conclusions Added bovine MFGM in a routine cow's milk-based infant formula through 12 months of age supported normal growth through 24 months of age. Funding Sources The study was funded by Mead Johnson Nutrition (MJN). Teresa Murguia-Peniche, Steven Wu, and Jennifer Wampler are currently employed by MJN. Carol Lynn Berseth was previously employed by MJN.

Assessing Early Indicators of Tolerance and Stool Microbiome in Infants Receiving Formula with Added Lactobacillus rhamnosus GG (LGG)

Abstract Objectives To evaluate stool microbiome and calprotectin in infants receiving partially hydrolyzed protein formula with or without Lactobacillus rhamnosus GG (LGG). Methods In this single-center, double-blind, controlled, parallel, prospective study, infants (14-28 days of age) experiencing crying/fussing often associated with infantile colic were randomized to receive one of two formulas over a 21-day feeding period: marketed partially hydrolyzed (PH) cow's milk-based infant formula (PH: n, 35) or a similar formula with added LGG (PH-LGG: n, 36). Stool samples were collected at Baseline and Study End (Days 19–21). Stool calprotectin (μg/g) was determined by immunoassay and analyzed (Kruskal-Wallis). LGG colonization was determined by qPCR analysis.16S rRNA gene sequencing was performed (Illumina MiSeq) and QIIME operational taxonomic units (OTUs) were assigned (Greengenes database). Alpha and beta diversity were analyzed by study group and time point. Results A significantly higher abundance of LGG was demonstrated at Study End vs Baseline for the PH-LGG (P &amp;lt; 0.001) but not PH group (P = 0.89). Alpha diversity (Shannon) was significantly higher at Study End vs Baseline in the PH group (P = 0.014). By Study End, members of Phylum Firmicutes were significantly higher (P = 0.002) and Family Enterococcaceae were significantly lower (P = 0.02) in the PH-LGG group. No group differences in stool calprotectin (median) were detected at Baseline (PH: 12.4, n = 26; PH-LGG: 13.9, n = 30) or Study End (PH: 12.4, n = 30; PH-LGG: 12.9, n = 30). Conclusions In infants receiving a partially hydrolyzed protein formula with added LGG over a 21-day feeding period, LGG was established in the stool microbiome. Associated potentially beneficial bacterial taxa were also increased. Funding Sources Mead Johnson Nutrition.

Assessing Early Behavioral Indicators of Tolerance in Infants Receiving Formula with Added Lactobacillus rhamnosus GG (LGG)

Abstract Objectives To evaluate the nutritive effects of an infant formula with added LGG on early behavioral indicators of tolerance in infants experiencing crying and fussing often associated with infantile colic. Methods In this single-center, double-blind, controlled, parallel, prospective study, infants (14 to 28 days of age) determined to cry and/or fuss ≥3 hours/day for ≥3 days/week (in a one-week period) were randomized to receive one of two formulas over a 21-day feeding period: marketed partially hydrolyzed (PH) cow's milk-based infant formula (PH: n, 35) or a similar formula with added LGG (PH-LGG: n, 36). Parents/caregivers used a validated parent-report diary to record crying/fussing and awake/content behavior at three time points: Study Days 2–4 (baseline), Days 10–12, and Days 18–20 (Study End). The primary outcome, duration (hours/day) of crying/fussing (averaged over each three-day period), was analyzed by repeated measures, mixed-effects models. Results Birth characteristics (sex, race, weight) and age (days; mean ± SE) at study entry (PH: 19.7 ± 0.8; PH-LGG: 19.3 ± 0.8) were similar for study groups. No group differences in mean study formula intake (g/day) or mean achieved weight (g) at any study time point were detected. Completion rates were similar through Day 21 (PH: n = 33, 94%; PH-LGG: n = 33, 92%). Duration of crying/fussing (mean ± SE) decreased over time with no significant differences detected in the PH vs PH-LGG group at Baseline (4.8 ± 0.3 vs 4.0 ± 0.3; P = 0.086), Days 10–12 (3.5 ± 0.3 vs 2.6 ± 0.3; P = 0.056), and Days 18–20 (2.1 ± 0.3 vs 1.5 ± 0.3; P = 0.227). Duration of awake/content behavior increased over time with no significant differences detected in PH vs PH-LGG: Baseline (1.0 ± 0.5 vs 1.2 ± 0.5; P = 0.786), Days 10–12 (1.3 ± 0.5 vs 1.6 ± 0.5; P = 0.627), and Days 18–20 (2.1 ± 0.5 vs 2.2 ± 0.5; P = 0.884). By Study End, only 8 (24%) in the PH and 9 (27%) in the PH-LGG group continued to cry and/or fuss ≥3 hours/day for ≥3 days/week. Conclusions In the present pilot study, we identified a study population of infants early in life experiencing crying and fussing often associated with infantile colic. Both study formulas were well tolerated. Crying/fussiness decreased and awake/content behavior increased in both study groups over the course of the study. Funding Sources Mead Johnson Nutrition.

Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial

To evaluate neurodevelopment, growth, and health outcomes in infants receiving bovine milk fat globule membrane (MFGM) and lactoferrin in infant formula. Healthy term infants were randomized to a cow's milk-based infant formula or MFGM+LF (a similar infant formula, with an added source of bovine milk fat globule membrane [bMFGM; whey protein-lipid concentrate, 5g/L] and bovine lactoferrin [0.6g/L]) through 365days of age. The Bayley Scales of Infant Development, 3rd edition cognitive composite score at day 365 was the primary outcome. Secondary outcomes included tolerance measures through day 365, additional neurodevelopmental and language outcomes, growth, and medically confirmed adverse events through day545. Of 451 infants enrolled (control, 228; MFGM+LF, 223), 291 completed study feeding and Bayley-III testing at day 365 (control, 148; MFGM+LF, 143). The mean cognitive (+8.7), language (+12.3), and motor (+12.6) scores were higher (P< .001) for the MFGM+LF group; no differences were observed at day 545. Global development scores from day 120 to day 275 and attention at day 365 were significantly improved. Few group differences in day 545 neurodevelopmental outcomes were detected, however scores of some subcategories of the MacArthur-Bates Communicative Development Inventories were higher (P< .05) in the MFGM+LF group. The overall incidence of respiratory-associated adverse events and diarrhea were significantly lower for the MFGM+LF group through day545. Infants receiving formula with added bovine MFGM and bovine lactoferrin had an accelerated neurodevelopmental profile at day 365 and improved language subcategories at day 545. Formulas were associated with age-appropriate growth and significantly fewer diarrhea and respiratory-associated adverse events through 545days of age. TRIAL REGISTRATION CLINICALTRIALS.GOV:: NCT02274883.

Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas

Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas

Early Exposure to Cow's Milk Protein Is Associated with a Reduced Risk of Cow's Milk Allergic Outcomes

Overall early exposure to allergenic foods in the infant's diet is a new strategy for preventing food allergy to that allergen, but the optimal timing of exposure for different allergens is not known. We aimed to examine the relationship between exposure to cow's milk protein in the first 3 months of life and risk of cow's milk allergy at age 12 months. HealthNuts is a longitudinal population-based food allergy study that recruited 5,276 twelve-month-old infants. Skin prick testing to cow's milk was conducted on the second half of the cohort (n= 2,715) and sensitization defined as a wheal ≥2 mm. Cow's milk allergy was defined as a parent-reported reaction to cow's milk consistent with IgE-mediated allergy together with evidence of sensitization. Early exposure to cow's milk protein was captured through parental questionnaire administered at 1 year of age and defined as consumption of cow's milk-based infant formula during the first 3 months of life. Forty-two percent of infants were exposed to cow's milk in the first 3 months of life (n= 1,977/4,712) and 87% of these infants were also breastfed. Early exposure to cow's milk protein was associated with a reduced risk of cow's milk sensitization (adjusted odds ratio [aOR] 0.44, 95% confidence interval [CI] 0.23-0.83), parent-reported reactions to cow's milk (aOR 0.44, 95% CI 0.29-0.67), and cow's milk allergy (aOR 0.31, 95% CI 0.10-0.91) at age 12 months. Age at exposure to cow's milk protein was not associated with the risk of other food allergies. Exposure to cow's milk protein in the first 3months of life was associated with a reduced risk of cow's milk allergy. These findings are from an observational study and clinical trials are warranted to further assess this association before any recommendations to infant feeding guidelines can be made.