METHODS: In a randomised double-blind controlled, parallel, multicountry intervention study, 767 healthy children, ages 11 to 29 months, received GUM with scGOS/lcFOS/LCPUFAs (the active group, n = 388), GUM without scGOS/lcFOS/LCPUFAs (the control group, n = 379), or cow's milk (n = 37) for 52 weeks. The primary outcome measure was the number of episodes of upper respiratory tract infections or gastrointestinal infections based on a combination of subject's illness symptoms reported by the parents during the intervention period.
RESULTS: Children in the active group compared with the control group had a decreased risk of developing at least 1 infection (299/388 [77%] vs 313/379 [83%], respectively, relative risk 0.93, 95% confidence interval [CI] 0.87-1.00; logistic regression P = 0.03). There was a trend toward a reduction (P = 0.07) in the total number of infections in the active group, which was significant when confirmed by one of the investigators (268/388 [69%] vs 293/379 [77%], respectively, relative risk 0.89, 95% CI 0.82-0.97; P = 0.004, post hoc). More infectious episodes were observed in the cow's milk group, when compared with both GUM groups (34/37 [92%] vs 612/767 [80%], respectively, relative risk 1.15, 95% CI 1.04-1.28).
CONCLUSIONS: This is the first study in children to show a reduced risk of infection following consumption of GUM supplemented with scGOS/lcFOS/n-3 LCPUFAs. The borderline statistical significance justifies a new study to confirm this finding.