Insights into Novel Infant Milk Formula Bioactives

Figures & data

Table 1 Human Clinical Research on Health Outcomes Related to Inclusion of Probiotics in Infant Milk Formulae

Author, Year	Region	Participants	Intervention	Outcomes
Escribano et al, 2018^Citation35	Spain	Healthy, term newborns born ≥37 weeks of gestation, with normal birth weight (3rd to 97th percentiles for gestational age), normal growth curve, ≤3 months of age at enrollment; N=151 completed.	Double-blinded, randomized, multicenter, controlled clinical trial; infant formula supplemented with 10^Citation7 cfu/g of B. infantis IMI (experimental), standard formula (control); 12-week study.	Reduced diarrhea episodes and lowered constipation prevalence in experimental group.
Simeoni et al, 2016^Citation36	Switzerland	Full term, exclusively formula-fed babies, mean age of 5 days; N=115.	Randomized, double-blind, control intervention; infant formula supplemented with a bovine milk oligosaccharide (5.7 ± 1.0 g/100 g of powder formula) and a B. lactis CNCM 1-3446 (10^7 cfu g/1 of powder formula; experimental), unsupplemented formula (control); 12-week study.	1) Higher faecal pH and higher diversity of faecal microbiota in control group; 2) B. lactis increased by 100-fold in the stool and was detected in all infants in the experimental group; 3) Increased endogenous Bifidobacteria (B. longum, B. breve, B. bifidum, B. pseudocatenulatum) in experimental group.

Table 2 Human Clinical Research on Health Outcomes Related to Inclusion of Polyunsaturated Fatty Acids in Infant Milk Formulae

Author, Year	Region	Participants	Intervention	Outcomes
Makrides et al, 1995^Citation53	Australia	Infants born between 37–42 weeks of gestation; mothers with no history of lipid metabolism disorders, insulin-dependent diabetes, drug or alcohol abuse; babies with appropriate weight for gestation; N=79 completed.	Formula supplemented with fish oil (experimental group), standard unsupplemented formula (control); 30-week study.	1) Visual evoked potential was improved in the experimental group; 2) Erythrocyte DHA was elevated in experimental group; 3) Erythrocyte ARA was decreased in experimental group.
Pastor et al, 2006^Citation55	Spain	Healthy infants, born after 36 weeks gestation; N=1342.	Open label clinical trial; 2 groups: formula with 34 mg AA and 17 mg DHA (experimental) vs no added AA/DHA or low amount ranging from 6–13 mg AA and 8–16 mg DHA (control); 12-month study.	1) Similar growth rates among groups; 2) Treatment group had lower incidence of bronchiolitis/ bronchitis vs control; 3) Lower occurrence of rhinitis and lower incidence of upper airway infection in the experimental group vs control.
Lapillonne et al, 2014^Citation56	France	Healthy, term infants born after 37 weeks of gestation, singleton, less than 60 days of age at enrollment; birth weight, length, and head circumference appropriate for gestational age (≥10th and ≤90th percentile); N=325.	Multi-center clinical trial; infants consumed formula with 17 mg DHA and 34 mg ARA/100 kcal (experimental) or with no added DHA or ARA (control); duration of study was until 1 year of age	1) Lower incidence of bronchitis, croup, nasal congestion, cough in experimental group; 2) Diarrhea that required medical attention was lower in experimental group; 3) Odds ratio of increased number of incidences of respiratory illness and diarrhea was lower in experimental group.
Foiles et al, 2016^Citation57	USA	Healthy infants, exclusively formulafed, singleton-birth, born between 37–42 weeks of gestation, birth weight between 2490 and 4200 grams, ≤ 9 days old at time of randomization; N=91.	Four-year follow-up on cohorts that consumed formula supplemented with PUFA (experimental) or without PUFA (control).	1) Lower incidence of allergic diseases and skin allergy in first year of life in experimental group; 2) Longer mean time until first allergic illness in experimental group; 3) Possible reduced risks of allergic disease, wheezing, asthma in experimental group.
Miklavcic et al, 2017^Citation58	Canada	Infants less than 21 days of age, singleton birth, healthy, had body weight, length, and head circumference between the 10th and 90th percentile; N=89.	Prospective, double-blind controlled study; formula containing 17 mg DHA and 0, 25, or 34 mg ARA/100 kcal; 10-week study.	1) Plasma ARA level lower in group consuming formula without ARA; 2) Higher proportion of B cells and activation markers in group consuming formula without ARA.

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Pastor N, Soler B, Mitmesser SH, Ferguson P, Lifschitz C. Infants fed docosahexaenoic acid- and arachidonic acid-supplemented formula have decreased incidence of bronchiolitis/bronchitis the first year of life. Clin Pediatr (Phila). 2006;45(9):850–855. doi:10.1177/1073858406289801

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Foiles AM, Kerling EH, Wick JA, Scalabrin DM, Colombo J, Carlson SE. Formula with long-chain polyunsaturated fatty acids reduces incidence of allergy in early childhood. Pediatr Allergy Immunol. 2016;27(2):156–161. doi:10.1111/pai.12515

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