PMID- 32698596
OWN - NLM
STAT- MEDLINE
DCOM- 20210812
LR  - 20210812
IS  - 1699-5198 (Electronic)
IS  - 0212-1611 (Linking)
VI  - 37
IP  - 4
DP  - 2020 Aug 27
TI  - Real-world study in infants fed with an infant formula with two human milk 
      oligosaccharides.
PG  - 698-706
LID - 10.20960/nh.03084 [doi]
AB  - Introduction: human milk oligosaccharides (HMOs) are an important component of 
      human milk supporting the development of a balanced intestinal microbiota and 
      immune protection in breastfed infants. Randomized controlled trials (RCTs) have 
      demonstrated that infant formulas supplemented with the HMOs 2'-fucosyllactose 
      (2'FL) and lacto-N-neotetraose (LNnT) are safe, well-tolerated, and support 
      normal growth. This Real-World Evidence (RWE) study aimed to evaluate growth and 
      tolerance in infants consuming a formula supplemented with 1 g/L of 2'FL and 0.5 
      g/L of LNnT, and included a mixed-feeding group never studied before in RCTs. 
      Participants and methods: this open-label, prospective study was conducted at six 
      centers in Spain, and included healthy, exclusively breastfed infants (BF group), 
      an exclusively formula-fed group (FF) who received a milk-based formula with 2' 
      FL and LNnT, and a group mixed fed with both formula and human milk (MF), for 8 
      weeks. Co-primary outcomes were growth (anthropometry) and gastrointestinal 
      tolerance (Infant Gastrointestinal Symptom Questionnaire, IGSQ). Secondary 
      outcomes included formula satisfaction and adverse events (AEs). Results: 159 
      infants completed the study (66 FF, 48 MF, and 45 BF). Mean z-scores for growth 
      were similar between all groups and within +/- 0.5 of WHO medians at week 8. 
      Composite IGSQ scores demonstrated low GI distress in all groups, with no 
      significant group differences at baseline, week 4, or week 8. Incidence of AEs 
      was low overall, and comparable across groups. Conclusions: in this RWE study 
      examining a HMO-supplemented infant formula, growth and tolerance outcomes were 
      similar to RCT findings, supporting the effectiveness of this early feeding 
      option.
FAU - Roman, Enriqueta
AU  - Roman E
AD  - Hospital Universitario Puerta de Hierro Majadahonda.
FAU - Moreno Villares, Jose Manuel
AU  - Moreno Villares JM
AD  - Clinica Universidad de Navarra.
FAU - Dominguez Ortega, Francisco
AU  - Dominguez Ortega F
AD  - Hospital Vithas Santa Catalina.
FAU - Carmona Martinez, Alfonso
AU  - Carmona Martinez A
AD  - Grupo Hispalense de Pediatria.
FAU - Pico Sirvent, Leandro
AU  - Pico Sirvent L
AD  - Hospital Casa de la Salud, Valencia.
FAU - Santana Sandoval, Luz
AU  - Santana Sandoval L
AD  - Hospital Universitraio Quiron-Dexeus.
FAU - Casas Rivero, Jose
AU  - Casas Rivero J
AD  - Hospital Ruber Internacional.
FAU - Alshweki, Ayham
AU  - Alshweki A
AD  - Hospital Materna MH Belen.
FAU - Cercamondi, Colin
AU  - Cercamondi C
AD  - Nestle Product Technology Center.
FAU - Dahbane, Samir
AU  - Dahbane S
AD  - Global Medical Affairs, Nestle Nutrition.
FAU - Vidal Guevara, Maria Luisa
AU  - Vidal Guevara ML
AD  - Medical & Scientific Affairs, Nutricion Infantil, Nestle.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
TT  - Estudio en condiciones reales de lactantes alimentados con una formula infantil 
      con dos oligosacaridos de leche humana.
PL  - Spain
TA  - Nutr Hosp
JT  - Nutricion hospitalaria
JID - 9100365
RN  - 0 (Oligosaccharides)
RN  - 0 (Trisaccharides)
RN  - BY63N40B1L (lacto-N-neotetraose)
RN  - XO2533XO8R (2'-fucosyllactose)
SB  - IM
MH  - Female
MH  - Humans
MH  - Infant
MH  - Infant Formula/*chemistry
MH  - Infant, Newborn
MH  - Male
MH  - Milk, Human/chemistry
MH  - Oligosaccharides/*administration & dosage/analysis
MH  - Prospective Studies
MH  - Trisaccharides/*administration & dosage/analysis
OTO - NOTNLM
OT  - Formula para lactantes. Oligosacaridos de la leche materna. 2'fucosilactosa. 
      Lacto-N-neotetraosa. Tolerancia gastrointestinal.
EDAT- 2020/07/24 06:00
MHDA- 2021/08/13 06:00
CRDT- 2020/07/24 06:00
PHST- 2020/07/24 06:00 [pubmed]
PHST- 2021/08/13 06:00 [medline]
PHST- 2020/07/24 06:00 [entrez]
AID - 10.20960/nh.03084 [doi]
PST - ppublish
SO  - Nutr Hosp. 2020 Aug 27;37(4):698-706. doi: 10.20960/nh.03084.