PMID- 35193609
OWN - NLM
STAT- MEDLINE
DCOM- 20220407
LR  - 20220407
IS  - 1475-2891 (Electronic)
IS  - 1475-2891 (Linking)
VI  - 21
IP  - 1
DP  - 2022 Feb 22
TI  - Safety and efficacy of a probiotic-containing infant formula supplemented with 
      2'-fucosyllactose: a double-blind randomized controlled trial.
PG  - 11
LID - 10.1186/s12937-022-00764-2 [doi]
LID - 11
AB  - BACKGROUND: Human 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). METHODS: Healthy 
      infants < 14 days old (n = 289) were randomly assigned to a bovine milk-based 
      formula containing L. reuteri DSM 17938 at 1 x 10(7) 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. RESULTS: Weight 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. CONCLUSION: L. 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 
      REGISTRATION: The trial was registered on ClinicalTrials.gov ( NCT03090360 ) 
      on 24/03/2017.
CI  - (c) 2022. The Author(s).
FAU - Alliet, Philippe
AU  - Alliet P
AD  - Department of Pediatrics, Jessa Hospital, Hasselt, Belgium.
FAU - Vandenplas, Yvan
AU  - Vandenplas Y
AD  - KidZ Health Castle, Vrije Universiteit Brussel, UZ Brussel, Brussels, Belgium.
FAU - Roggero, Paola
AU  - Roggero P
AD  - Department of Clinical Sciences and Community Health, University of Milan, Milan, 
      Italy.
FAU - Jespers, Sabine N J
AU  - Jespers SNJ
AD  - Clinique Et Maternite Sainte-Elisabeth, Namur, Belgium.
FAU - Peeters, Stefaan
AU  - Peeters S
AD  - Algemeen Stedelijk Ziekenhuis Aalst, Aalst, Belgium.
FAU - Stalens, Jean-Philippe
AU  - Stalens JP
AD  - Department of Pediatrics, Centre Hospitalier de Wallonie Picarde, Tournai, 
      Belgium.
FAU - Kortman, Guus A M
AU  - Kortman GAM
AD  - NIZO Food Research BV, Ede, The Netherlands.
FAU - Amico, Mailis
AU  - Amico M
AD  - Biostatistics & Data, Nestle Research, Societe des Produits Nestle S.A., 
      Lausanne, Switzerland.
FAU - Berger, Bernard
AU  - Berger B
AD  - Nestle Institute of Health Sciences, Nestle Research, Societe des Produits Nestle 
      S.A., Lausanne, Switzerland.
FAU - Sprenger, Norbert
AU  - Sprenger N
AD  - Nestle Institute of Health Sciences, Nestle Research, Societe des Produits Nestle 
      S.A., Lausanne, Switzerland.
FAU - Cercamondi, Colin I
AU  - Cercamondi CI
AD  - Nestle Product Technology Center - Nutrition, Societe des Produits Nestle S.A., 
      Vevey, Switzerland. colinivano.cercamondi@nestle.com.
FAU - Corsello, Giovanni
AU  - Corsello G
AD  - Department of Health Promotion Sciences Maternal and Infant Care, University of 
      Palermo, Palermo, Italy.
LA  - eng
SI  - ClinicalTrials.gov/NCT03090360
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220222
PL  - England
TA  - Nutr J
JT  - Nutrition journal
JID - 101152213
RN  - 0 (Oligosaccharides)
RN  - 0 (Trisaccharides)
RN  - XO2533XO8R (2'-fucosyllactose)
SB  - IM
MH  - Double-Blind Method
MH  - Feces/microbiology
MH  - Humans
MH  - Infant
MH  - *Infant Formula
MH  - Milk, Human/chemistry
MH  - Oligosaccharides
MH  - Phylogeny
MH  - *Probiotics
MH  - Trisaccharides
PMC - PMC8862345
OTO - NOTNLM
OT  - 2'fucosyllactose
OT  - Growth
OT  - Gut microbiome
OT  - Human milk oligosaccharides
OT  - Infant formula
COIS- Mailis Amico, Bernard Berger, Norbert Sprenger, and Colin I. Cercamondi are 
      current employees of Societe des Produits Nestle S.A. Guus A. M. Kortman is an 
      employee of NIZO Food Research BV. The remaining authors declare that they have 
      no competing interests that are relevant to the content of this article.
EDAT- 2022/02/24 06:00
MHDA- 2022/04/08 06:00
PMCR- 2022/02/22
CRDT- 2022/02/23 05:29
PHST- 2021/09/08 00:00 [received]
PHST- 2022/02/08 00:00 [accepted]
PHST- 2022/02/23 05:29 [entrez]
PHST- 2022/02/24 06:00 [pubmed]
PHST- 2022/04/08 06:00 [medline]
PHST- 2022/02/22 00:00 [pmc-release]
AID - 10.1186/s12937-022-00764-2 [pii]
AID - 764 [pii]
AID - 10.1186/s12937-022-00764-2 [doi]
PST - epublish
SO  - Nutr J. 2022 Feb 22;21(1):11. doi: 10.1186/s12937-022-00764-2.