Safety and efficacy of a probiotic-containing infant formula supplemented with 2’-fucosyllactose: a double-blind randomized controlled trial

Nutrition Journal

Stefaan Peeters¹  Mailis Amico²  Sabine N. J. Jespers³  Paola Roggero⁴  Giovanni Corsello⁵  Jean-Philippe Stalens⁶  Philippe Alliet⁷  Yvan Vandenplas⁸  Guus A. M. Kortman⁹  Norbert Sprenger^1,10  Bernard Berger^1,10  Colin I. Cercamondi^1,11 

[1] Algemeen Stedelijk Ziekenhuis Aalst, Aalst, Belgium;Biostatistics & Data, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland;Clinique Et Maternité Sainte-Elisabeth, Namur, Belgium;Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy;Department of Health Promotion Sciences Maternal and Infant Care, University of Palermo, Palermo, Italy;Department of Pediatrics, Centre Hospitalier de Wallonie Picarde, Tournai, Belgium;Department of Pediatrics, Jessa Hospital, Hasselt, Belgium;KidZ Health Castle, Vrije Universiteit Brussel, UZ Brussel, Brussels, Belgium;NIZO Food Research BV, Ede, The Netherlands;Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland;Nestlé Product Technology Center – Nutrition, Société des Produits Nestlé S.A., Vevey, Switzerland;

关键词: Infant formula;    Human milk oligosaccharides;    2’fucosyllactose;    Growth;    Gut microbiome;   

DOI  :  10.1186/s12937-022-00764-2

来源: Springer

【 摘 要 】

BackgroundHuman milk oligosaccharides (HMOs) have important and diverse biological functions in early life. This study tested the safety and efficacy of a starter infant formula containing Limosilactobacillus (L.) reuteri DSM 17938 and supplemented with 2’-fucosyllactose (2’FL).MethodsHealthy infants < 14 days old (n = 289) were randomly assigned to a bovine milk-based formula containing L. reuteri DSM 17938 at 1 × 107 CFU/g (control group; CG) or the same formula with added 1.0 g/L 2’FL (experimental group; EG) until 6 months of age. A non-randomized breastfed group served as reference (BF; n = 60). The primary endpoint was weight gain through 4 months of age in the formula-fed infants. Secondary endpoints included additional anthropometric measures, gastrointestinal tolerance, stooling characteristics, adverse events (AEs), fecal microbiota and metabolism, and gut immunity and health biomarkers in all feeding groups.ResultsWeight gain in EG was non-inferior to CG as shown by a mean difference [95% CI] of 0.26 [-1.26, 1.79] g/day with the lower bound of the 95% CI above the non-inferiority margin (-3 g/day). Anthropometric Z-scores, parent-reported stooling characteristics, gastrointestinal symptoms and associated behaviors, and AEs were comparable between formula groups. Redundancy analysis indicated that the microbiota composition in EG was different from CG at age 2 (p = 0.050) and 3 months (p = 0.052), approaching BF. Similarly, between sample phylogenetic distance (weighted UniFrac) for BF vs EG was smaller than for BF vs CG at 3-month age (p = 0.045). At age 1 month, Clostridioides difficile counts were significantly lower in EG than CG. Bifidobacterium relative abundance in EG tracked towards that in BF. Fecal biomarkers and metabolic profile were comparable between CG and EG.ConclusionL. reuteri-containing infant formula with 2’FL supports age-appropriate growth, is well-tolerated and may play a role in shifting the gut microbial pattern towards that of breastfed infants.Trial RegistrationThe trial was registered on ClinicalTrials.gov (NCT03090360) on 24/03/2017.

【 授权许可】

CC BY