title: Partly Fermented Infant Formulae With Specific Oligosaccharides Support Adequate Infant Growth and Are Well-Tolerated.
abstract: Fermented formulae (FERM) and a specific mixture of 90% short-chain galacto-oligosaccharides and 10% long-chain fructo-oligosaccharides (scGOS/lcFOS; 9:1) have a potential beneficial effect on gastrointestinal function and microbiota development in infants. The present study assessed the safety and tolerance of the combination of partly fermented infant milk formulae and scGOS/lcFOS compared with either 1 feature, in healthy term infants.
  
  
  
  Four hundred thirty-two infants were enrolled before 28 days of age and followed up to 17 weeks of age and assigned to 1 of the 4 groups: (i) formula with scGOS/lcFOS, (ii) scGOS/lcFOS + 15% FERM, (iii) scGOS/lcFOS + 50% FERM, or (iv) 50% fermented formula (50% FERM). Primary outcome was daily weight gain during intervention (equivalence criterion: difference in daily weight gain ≤3 g/day). Infants' anthropometrics, formula intake, number, and type of (serious) AEs were monitored monthly. Stool samples were collected at baseline and after 17 weeks for analysis of physiological and microbiological parameters.
  
  
  
  Equivalence of weight gain per day was demonstrated in both the intention-to-treat and per-protocol population, with a mean weight gain (SD) of 29.7 (6.1), 28.2 (4.8), 28.5 (5.0), and 28.7 (5.9) g/day for the groups i to iv respectively. No differences were observed in other growth parameters, formula intake, and the number or severity of AEs. In all scGOS/lcFOS-containing formulae, a beneficial effect of scGOS/lcFOS was observed, indicated by the lower pH, lower Clostridium difficile levels, and higher secretory immunoglobulin A levels.
  
  
  
  The partly fermented infant milk formulae containing the specific mixture scGOS/lcFOS were well-tolerated and resulted in normal growth in healthy infants.
authors.affiliation: *Hôpital d'Enfants, Dijon, France †Nutricia Research, Utrecht, The Netherlands ‡Center Hospitalier Universitaire Vaudois, Lausanne, Switzerland §Maison de l'enfant Essey- lès- Nancy, Essey- lès- Nancy ||Center Hospitalier Universitaire d'Angers, Angers, France ¶Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium #Department of Paediatrics and Child Health, University College, Cork, Ireland.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Huet
authors.forename: Marieke
authors.initials: M
authors.lastname: Abrahamse-Berkeveld
authors.forename: Sebastian
authors.initials: S
authors.lastname: Tims
authors.forename: Umberto
authors.initials: U
authors.lastname: Simeoni
authors.forename: Gérard
authors.initials: G
authors.lastname: Beley
authors.forename: Christoph
authors.initials: C
authors.lastname: Savagner
authors.forename: Yvan
authors.initials: Y
authors.lastname: Vandenplas
authors.forename: Jonathan O'B
authors.initials: JO
authors.lastname: Hourihane
mesh_terms: D016360:Clostridioides difficile / Q000302:isolation & purification; D004311:Double-Blind Method; D005243:Feces / Q000382:microbiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000009:adverse effects; D007231:Infant, Newborn; D008297:Male; D009844:Oligosaccharides / Q000009:adverse effects; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D015430:Weight Gain
chemical_list: D009844:Oligosaccharides; C116580:fructooligosaccharide