A Partially Hydrolysed Formula with Synbiotics Supports Adequate Growth and Is Well-Tolerated in Healthy, Chinese Term Infants: A Double-Blind, Randomised, Controlled trial

Abstract Objectives This study evaluated growth and gastrointestinal tolerance in infants fed a partially hydrolysed protein formula (pHF) with a synbiotic mixture of short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides (scGOS/lcFOS (9:1)) and Bifidobacterium breve M-16V (Test) compared to an intact protein infant formula (IF) with scGOS/lcFOS (Control). Methods This randomized, double-blind, controlled, multi-centre trial enrolled healthy, Chinese, fully formula-fed infants (≤44 days) who received either the Test (n = 112) or Control formula (n = 112) until 17 weeks of age. Fully breastfed infants served as a reference (n = 60). Anthropometrics, gastrointestinal symptoms, and adverse events were assessed monthly. Primary outcome was weight gain in g/d from baseline to 17 weeks of age. Results Equivalence in daily weight gain (primary outcome) was demonstrated between the Test and Control groups [estimated mean difference (SE): -0.36 (0.93) g/day, 90%CI -1.90, 1.18] as well as between each IF group and the Breastfed reference group (Test: 0.02 (1.05) g/d, 90%CI -1.71, 1.75; Control: 0.36 (1.04) g/d, 90%CI -1.35, 2.08.]. There were no clinically relevant differences in gastrointestinal tolerance or adverse events between the formula groups. Conclusion A pHF with synbiotics supports adequate growth and is well-tolerated in healthy, Chinese, term-born infants. Additionally, infant growth and gastrointestinal tolerance measures of both IF groups were comparable to the breastfed group and can be considered as suitable for use and well-tolerated.