A partially hydrolyzed formula with synbiotics supports adequate growth and is well tolerated in healthy, Chinese term infants: A double-blind, randomized controlled trial.

2021-08-30
Nutrition (Burbank, Los Angeles County, Calif.) 91
- Ying Wang
- Zailing Li
- Jie-Ling Wu
- Lili Zhang
- Min Liu
- Meizhen Tan
- Akke Botma
- Mengjin Liu
- Kelly A Mulder
- Marieke Abrahamse-Berkeveld
- Wei Cai

PubMed: 34626956
DOI: 10.1016/j.nut.2021.111472

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 112
Population: healthy Chinese infants ≤44 days old
Methods: Randomized, double-blind, controlled, multicenter trial; infants received test formula (pHF with synbiotics) or control formula (intact protein IF with scGOS/lcFOS) until 17 wk of age
Blinding: Double-blind
Duration: until 17 wk of age
Funding: Unclear

Large Human Trial

Objectives

The aim of this study was to evaluate growth and gastrointestinal tolerance in infants fed a partially hydrolyzed protein formula (pHF) with a synbiotic mixture of short-chain galacto-oligosaccharides and long-chain fructooligosaccharides (scGOS/lcFOS; 9:1) and Bifidobacterium breve M-16V (test formula) compared with an intact protein infant formula (IF) with scGOS/lcFOS (control formula).

Methods

This randomized, double-blind, controlled, multicenter trial enrolled healthy, fully formula-fed Chinese infants (≤44 d) who received either the test (n = 112) or control formula (n = 112) until 17 wk 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 grams per day from baseline to 17 wk of age.

Results

Equivalence in daily weight gain (primary outcome) was demonstrated between the test and control groups (estimated mean difference [0.93] g/d, 90% confidence interval [CI], -1.90 to 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 to 1.75; control: 0.36 [1.04] g/d, 90% CI, -1.35 to 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, term-born Chinese infants. Additionally, infant growth and gastrointestinal tolerance measures of both IF groups were comparable to the breastfed group and can be considered suitable and well tolerated for use.