Growth, Tolerance, and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula with Added 2′-FL Fucosyllactose (2′-FL) Human Milk Oligosaccharide

Background: The purpose of this study was to evaluate the growth, tolerance and compliance effects of an extensively hydrolyzed formula with added 2′-FL in an intended use population of infants. Methods: A non-randomized, single-group, multicenter study was conducted. Infants (0–60 days of age) with suspected food protein allergy, persistent feeding intolerance, or presenting conditions where an extensively hydrolyzed formula (eHF) was deemed appropriate were enrolled in a 2-month feeding trial. The primary outcome was maintenance of weight for age z-score during the study. Weight, length, head circumference, formula intake, tolerance measures, clinical symptoms and questionnaires were collected. Forty-eight infants were enrolled and 36 completed the study. Results: Weight for age z-scores of infants showed a statistically significant improvement from study day 1 to study day 60 (0.32 ± 0.11, p = 0.0078). Conclusions: Overall, the results of the study demonstrate that the study formula was well tolerated, safe and supported growth in the intended population.

[1]  A. Nowak‐Wegrzyn,et al.  Confirmed Hypoallergenicity of a Novel Whey-Based Extensively Hydrolyzed Infant Formula Containing Two Human Milk Oligosaccharides , 2019, Nutrients.

[2]  A. Devitt,et al.  Review of the Clinical Experiences of Feeding Infants Formula Containing the Human Milk Oligosaccharide 2′-Fucosyllactose , 2018, Nutrients.

[3]  P. Forsythe,et al.  Human Milk Oligosaccharides Attenuate Antigen-Antibody Complex Induced Chemokine Release from Human Intestinal Epithelial Cell Lines. , 2018, Journal of food science.

[4]  Karen C. Goehring,et al.  Similar to Those Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory Cytokines in a Randomized Controlled Trial. , 2016, The Journal of nutrition.

[5]  J. Oliver,et al.  Gastrointestinal Tolerance of Formula Supplemented with Oligosaccharides , 2016, The FASEB Journal.

[6]  Jennifer A. Williams,et al.  Infants Fed a Lower Calorie Formula With 2′FL Show Growth and 2′FL Uptake Like Breast-Fed Infants , 2015, Journal of pediatric gastroenterology and nutrition.

[7]  P. Forsythe,et al.  Attenuation of food allergy symptoms following treatment with human milk oligosaccharides in a mouse model , 2015, Allergy.

[8]  M. Borschel,et al.  A New Hydrolyzed Formula is Well Tolerated in Infants with Suspected Food Protein Allergy or Intolerance , 2015 .

[9]  B. Barrett-Reis,et al.  Growth of Healthy Term Infants Fed Ready-to-Feed and Powdered Forms of an Extensively Hydrolyzed Casein-Based Infant Formula , 2014, Clinical pediatrics.

[10]  Lars Bode,et al.  Human milk oligosaccharides: every baby needs a sugar mama. , 2012, Glycobiology.

[11]  L. Bode,et al.  Human milk oligosaccharides and their potential benefits for the breast-fed neonate. , 2012, Minerva pediatrica.

[12]  C. Lebrilla,et al.  Human milk glycobiome and its impact on the infant gastrointestinal microbiota , 2010, Proceedings of the National Academy of Sciences.

[13]  Tadashi Nakamura,et al.  Variation of major neutral oligosaccharides levels in human colostrum , 2008, European Journal of Clinical Nutrition.

[14]  M. Altaye,et al.  Fucosylated human milk oligosaccharides vary between individuals and over the course of lactation. , 2001, Glycobiology.

[15]  W. T. Malone,et al.  Variability of human milk neutral oligosaccharides in a diverse population. , 2000, Journal of pediatric gastroenterology and nutrition.

[16]  S. Thurl,et al.  Variations of neutral oligosaccharides and lactose in human milk during the feeding , 1993, Zeitschrift fur Ernahrungswissenschaft.

[17]  L. Grummer-Strawn,et al.  Use of World Health Organization and CDC growth charts for children aged 0-59 months in the United States. , 2010, MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports.

[18]  D. Newburg Neonatal protection by an innate immune system of human milk consisting of oligosaccharides and glycans. , 2009, Journal of animal science.