PMID- 37597076
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231121
IS  - 2194-7791 (Print)
IS  - 2194-7791 (Electronic)
IS  - 2194-7791 (Linking)
VI  - 10
IP  - 1
DP  - 2023 Aug 19
TI  - Real-world evidence study on tolerance and growth in infants fed an infant 
      formula with two human milk oligosaccharides vs mixed fed and exclusively 
      breastfed infants.
PG  - 7
LID - 10.1186/s40348-023-00162-6 [doi]
LID - 7
AB  - INTRODUCTION: Human milk oligosaccharides (HMOs) are important components of 
      human milk having diverse functions in the development of infants. Randomized 
      controlled trials (RCTs) have demonstrated that infant formulas with the HMOs 
      2'-fucosyllactose (2'FL) and lacto-N-neotetraose (LNnT) are safe, well-tolerated, 
      and support normal growth. This study aimed to generate real-world evidence (RWE) 
      on growth and gastrointestinal (GI) tolerance in infants consuming a formula with 
      1 g/L 2'FL and 0.5 g/L LNnT, including a mixed feeding group not studied before 
      in RCTs. PARTICIPANTS AND METHODS: This 8-week open-label prospective multicenter 
      study was conducted in Germany and Austria, and included groups of healthy, 
      exclusively breastfed infants (BF), exclusively formula-fed infants (FF) who 
      received the HMO-formula, and infants mixed fed with both HMO formula and human 
      milk (MF). Co-primary outcomes were anthropometry and gastrointestinal tolerance 
      via validated Infant Gastrointestinal Symptom Questionnaire (IGSQ). Secondary 
      outcomes included formula satisfaction and adverse events (AEs). RESULTS: 
      One-hundred six infants completed the study (46 FF, 22 MF, and 38 BF). Mean 
      anthropometric z-scores were comparable between groups and generally within +/- 0.5 
      of WHO medians at week 8. IGSQ composite scores demonstrated good GI tolerance in 
      all groups with no significant group differences at week 4 or 8. IGSQ composite 
      scores in FF improved during the course of the study and parents provided high 
      satisfaction ratings for the HMO-formula. Four potentially product-related AEs 
      were reported in FF (no in MF). CONCLUSIONS: In this RWE study examining an 
      infant formula with HMOs, growth and GI tolerance outcomes were confirming the 
      good tolerance and safety of this early feeding option previously reported in 
      RCTs.
CI  - (c) 2023. Springer Nature Switzerland AG.
FAU - Jochum, Frank
AU  - Jochum F
AD  - Klinik fur Kinder- und Jugendmedizin, Ev. Waldkrankenhaus Spandau Stadtrandstr. 
      555, 13589, Berlin und Medizinische Hochschule Brandenburg - Theodor Fontane 
      (MHB), 16816, Neuruppin, Germany. frank.jochum@jsd.de.
FAU - Meyer-Krott, Martina
AU  - Meyer-Krott M
AD  - Kinderarztpraxis, Moses-Stern. Str. 28, 41236, Monchengladbach, Germany.
FAU - Hubler, Tina
AU  - Hubler T
AD  - Gemeinschaftspraxis Kinder- und Jugendarztpraxis, Clemensstrasse 4, 47608, 
      Geldern, Germany.
FAU - Lorenz, Maja
AU  - Lorenz M
AD  - Kinder- und Jugendarzt, Venloer Strasse 67, 41751, Viersen, Germany.
FAU - Bedikian, Raffi
AU  - Bedikian R
AD  - Kinder- und Jugendarztliche Gemeinschaftspraxis, Eugen-Zur-Nieden-Ring 1, 46145, 
      Oberhausen, Germany.
FAU - Zakarian, Joseph
AU  - Zakarian J
AD  - Kinderarztpraxis, Suitbertusstr. 31, 40223, Dusseldorf, Germany.
FAU - Litzka, Anja
AU  - Litzka A
AD  - Facharztpraxis fur Kinder- und Jugendmedizin, Regensburger Str. 40, 93133, 
      Burglengenfeld, Germany.
FAU - Judex, Guido
AU  - Judex G
AD  - Zentrum fur Kinder- und Jugendgesundheit Regensburg, Dr.-Leo-Ritter-Str. 4, 
      93049, Regensburg, Germany.
FAU - Hertzberg, Holger
AU  - Hertzberg H
AD  - Kinder- und Jugendarztpraxis, Ludwigstrasse 4, 91126, Schwabach, Germany.
FAU - Klee, Daniela
AU  - Klee D
AD  - Kinder- und Jugendarzt, Rontgen-Str. 6, 68642, Burstadt, Germany.
FAU - Maurer, Lothar
AU  - Maurer L
AD  - Facharzte fur Sauglings-, Kinder- und Jugendmedizin, Welschgasse 39, 67227, 
      Frankenthal, Germany.
FAU - Schacht, Martin
AU  - Schacht M
AD  - Facharzt fur Sauglings-, Kinder- und Jugendmedizin, Schwachhauser Heerstr. 63a, 
      28211, Bremen, Germany.
FAU - Al-Radhi, Adnan
AU  - Al-Radhi A
AD  - Kinder- und Jugendarzt Al-Radhi, Winckelhoferstrasse 3, 89584, Ehingen, Germany.
FAU - Maier, Jan
AU  - Maier J
AD  - Kinder und Jugendarztpraxis, Geranienstr. 11, 70771, Leinfelden-Echterdingen, 
      Germany.
FAU - Krockel, Alexander
AU  - Krockel A
AD  - Kinder- und Jugendarztpraxis, Schwarzwurzelstrasse 52/54, 12689, Berlin, Germany.
FAU - Faustmann, Christian
AU  - Faustmann C
AD  - Facharzt fur Kinder- und Jugendheilkunde, Wiener Strasse 8a, 7400, Oberwart, 
      Austria.
FAU - Lavalle, Luca
AU  - Lavalle L
AD  - Nestle Research, Societe des Produits Nestle S.A., Lausanne, Switzerland.
FAU - Dahbane, Samir
AU  - Dahbane S
AD  - Global Medical Affairs, Societe des Produits Nestle S.A., Vevey, Switzerland.
LA  - eng
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
GR  - NCT05150288/Societe des Produits Nestle S.A., Vevey, Switzerland/
PT  - Journal Article
DEP - 20230819
PL  - Germany
TA  - Mol Cell Pediatr
JT  - Molecular and cellular pediatrics
JID - 101660689
PMC - PMC10439867
OTO - NOTNLM
OT  - 2'-Fucosyllactose
OT  - Growth
OT  - Infant Gastrointestinal Symptom Questionnaire
OT  - Infant formula tolerance
OT  - Lacto-N-neotetraose
OT  - Real-world evidence
COIS- -LL and SD are current employees of Societe des Produits Nestle S.A., Vevey, 
      Switzerland. -This study was supported by Societe des Produits Nestle S.A.
EDAT- 2023/08/19 20:42
MHDA- 2023/08/19 20:43
PMCR- 2023/08/19
CRDT- 2023/08/19 11:06
PHST- 2023/02/27 00:00 [received]
PHST- 2023/08/04 00:00 [accepted]
PHST- 2023/08/19 20:43 [medline]
PHST- 2023/08/19 20:42 [pubmed]
PHST- 2023/08/19 11:06 [entrez]
PHST- 2023/08/19 00:00 [pmc-release]
AID - 10.1186/s40348-023-00162-6 [pii]
AID - 162 [pii]
AID - 10.1186/s40348-023-00162-6 [doi]
PST - epublish
SO  - Mol Cell Pediatr. 2023 Aug 19;10(1):7. doi: 10.1186/s40348-023-00162-6.