PMID- 33958719
OWN - NLM
STAT- MEDLINE
DCOM- 20220616
LR  - 20230201
IS  - 1530-0447 (Electronic)
IS  - 0031-3998 (Print)
IS  - 0031-3998 (Linking)
VI  - 91
IP  - 6
DP  - 2022 May
TI  - Infant formula containing bovine milk-derived oligosaccharides supports 
      age-appropriate growth and improves stooling pattern.
PG  - 1485-1492
LID - 10.1038/s41390-021-01541-3 [doi]
AB  - BACKGROUND: Adding bovine milk-derived oligosaccharides (MOS) enhances the 
      oligosaccharide profile of infant formula. This study aimed to evaluate the 
      safety and efficacy of a MOS-supplemented infant formula. METHODS: In this 
      double-blind randomized controlled trial, healthy infants 21-26 days old were 
      either assigned to bovine milk-based, alpha-lactalbumin, and sn-2 palmitate 
      enriched infant formula (control, n = 115) or the same formula with 7.2 g MOS/L 
      (test, n = 115) until aged 6 months. Co-primary endpoints were weight gain 
      through 4 months and stool consistency (validated scale: 1 = watery to 5 = hard). 
      Secondary endpoints included parent-reported GI tolerance, health-related quality 
      of life (HRQoL), and adverse events (AEs). RESULTS: Weight gain was similar 
      (p = 0.695); the difference between test and control (mean; 95% CI: 0.29; -1.15, 
      1.73 g/day) was above the non-inferiority margin (-3 g/day). Test had softer 
      stools than control (mean difference in stool consistency score: -0.31; 95% CI: 
      -0.42, -0.21; P < 0.0001); fewer parental reports of harder stools (OR = 0.32, 
      95% CI: 0.20, 0.49; P < 0.0001) and less difficulties in passing stool 
      (OR = 0.25, 95% CI: 0.09, 0.65; P = 0.005). Parent-reported GI tolerance and 
      HRQoL were similar between groups as were the overall low AEs. CONCLUSIONS: 
      MOS-supplemented infant formula is safe and well-tolerated while supporting 
      normal infant growth and promotes softer stooling pattern without increasing 
      parent-reported and physician-confirmed adverse health concerns. IMPACT: This is 
      the first study investigating the addition of bovine milk-derived 
      oligosaccharides to an infant formula enriched with alpha-lactalbumin and 
      elevated levels of sn-2 palmitate, providing safety and efficacy data for such a 
      formula. Term infant formula supplemented with 7.2 g bovine milk-derived 
      oligosaccharides per liter supported normal infant growth, was well-tolerated and 
      safe. Addition of bovine milk-derived oligosaccharides to term infant formula 
      promoted softer stooling pattern and reduced difficulties in passing stool. The 
      study shows that bovine milk-derived oligosaccharide supplemented infant formula 
      is a safe and effective option for healthy term infants who are formula-fed.
CI  - (c) 2021. The Author(s).
FAU - Estorninos, E
AU  - Estorninos E
AD  - Asian Hospital and Medical Center, Muntinlupa City, Philippines.
FAU - Lawenko, R B
AU  - Lawenko RB
AD  - Asian Hospital and Medical Center, Muntinlupa City, Philippines.
FAU - Palestroque, E
AU  - Palestroque E
AD  - Asian Hospital and Medical Center, Muntinlupa City, Philippines.
FAU - Lebumfacil, J
AU  - Lebumfacil J
AD  - Wyeth Nutrition, Makati City, Manila, Philippines.
FAU - Marko, M
AU  - Marko M
AD  - Nestle Product Technology Center - Nutrition, Societe des Produits Nestle S.A., 
      Vevey, Switzerland.
FAU - Cercamondi, C I
AU  - Cercamondi CI
AD  - Nestle Product Technology Center - Nutrition, Societe des Produits Nestle S.A., 
      Vevey, Switzerland. ColinIvano.Cercamondi@nestle.com.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210506
PL  - United States
TA  - Pediatr Res
JT  - Pediatric research
JID - 0100714
RN  - 0 (Oligosaccharides)
RN  - 0 (Palmitates)
RN  - 9013-90-5 (Lactalbumin)
SB  - IM
MH  - Animals
MH  - Double-Blind Method
MH  - Feces
MH  - Humans
MH  - Infant
MH  - *Infant Formula
MH  - Lactalbumin
MH  - *Milk
MH  - Oligosaccharides/adverse effects
MH  - Palmitates
MH  - Quality of Life
MH  - Weight Gain
PMC - PMC9197766
COIS- M.M., J.L., and C.I.C. were or are current employees of Societe des Produits 
      Nestle S.A. The remaining authors declare no competing interests.
EDAT- 2021/05/08 06:00
MHDA- 2022/06/18 06:00
PMCR- 2021/05/06
CRDT- 2021/05/07 07:00
PHST- 2020/12/21 00:00 [received]
PHST- 2021/04/07 00:00 [accepted]
PHST- 2021/03/17 00:00 [revised]
PHST- 2021/05/08 06:00 [pubmed]
PHST- 2022/06/18 06:00 [medline]
PHST- 2021/05/07 07:00 [entrez]
PHST- 2021/05/06 00:00 [pmc-release]
AID - 10.1038/s41390-021-01541-3 [pii]
AID - 1541 [pii]
AID - 10.1038/s41390-021-01541-3 [doi]
PST - ppublish
SO  - Pediatr Res. 2022 May;91(6):1485-1492. doi: 10.1038/s41390-021-01541-3. Epub 2021 
      May 6.