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.
Keywords: 2′-FL; cow milk allergy; formula intolerance; human milk oligosaccharide; hydrolyzed formula.