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

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. A non-randomized, single-group, multicenter study was conducted. Infants (0-60 days of age) with suspected food...

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Bibliographic Details
Published in:Nutrients 2021-01, Vol.13 (1), p.186
Main Authors: Ramirez-Farias, Carlett, Baggs, Geraldine E, Marriage, Barbara J
Format: Article
Language:English
Subjects:
Age
Antibiotics
Babies
Baby foods
Birth weight
Body Weight
Breast milk
Breastfeeding & lactation
Compliance
Constipation
Enrollments
Ethnicity
Extremely high frequencies
Female
Food allergies
Food Hypersensitivity - prevention & control
Food intolerance
Growth
Humans
Hydrolysis
Immune Tolerance
Infant
Infant Formula
Infant formulas
Infant, Newborn
Infants
Male
Milk
Milk Hypersensitivity - epidemiology
Milk Hypersensitivity - physiopathology
Milk Hypersensitivity - prevention & control
Milk Proteins - adverse effects
Milk, Human - chemistry
Nutrition
Oligosaccharides
Parents & parenting
Pharmaceutical industry
Proteins
Questionnaires
Statistical analysis
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Summary: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. 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. 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). Overall, the results of the study demonstrate that the study formula was well tolerated, safe and supported growth in the intended population.
ISSN:2072-6643
2072-6643
DOI:10.3390/nu13010186