Objective: The aim of this study was to investigate the effect of growing-up milk (GUM) with added short-chain galacto-oligosaccharides (scGOS)/long-chain fructo-oligosaccharides (lcFOS) (9:1) (Immunofortis) and n-3 long-chain polyunsaturated fatty acids (LCPUFAs) on the occurrence of infections in healthy children attending day care centres.
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.
*Department of Medicine, Division of Allergy and Immunology, Chulalongkorn University, Bangkok, Thailand
†Department of Pediatrics, University Malaya Medical Centre, Kuala Lumpur, Malaysia
‡Department of Paediatrics, Clinica Pediatrica da Amadora, Amadora, Portugal
§Department of Pediatrics, Division of Pediatric Gastroenterology, Khon Kaen University, Khon Kaen, Thailand
||Department of Pediatrics, Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima, Thailand
¶Nutricia Research, Utrecht, The Netherlands
#Department of Paediatrics, Medical University of Warsaw, Warsaw, Poland.
Address correspondence and reprint requests to Patricia Logtens-de Graaff, Nutricia Research, Utrecht, The Netherlands (e-mail: email@example.com).
Drs Chatchatee and Lee participated equally in this study.
www.trialregister.nl registration no.: NTR1451.
Y.Y., B.S., and P.L. are employees of Nutricia Research. The other authors report no conflicts of interest.
This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work, provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/3.0.
Received April 9, 2013
Accepted November 15, 2013