Abstract
Objective: We investigated the effects of lactoferrin (LF)-fortified formula on acute gastrointestinal and respiratory symptoms in children.Design: Randomized, double-blind, placebo-controlled trial.Setting and subjects: Children aged 12–32 months in Japan.Intervention: Intake of placebo or LF (48 mg/day)-fortified formula for 13 weeks.Primary endpoint: Prevalence of acute gastrointestinal and respiratory symptom.Results: One hundred nine participants were randomized. Eight participants were lost to follow-up, withdrew consent, or were deemed inappropriate for the trial, with 101 participants receiving complete analyses (placebo group, n = 48; LF group, n = 53).Outcomes: The prevalence of acute gastrointestinal symptoms was significantly less in the LF group (22/53 [41.5%]) than in the placebo group (30/48 [62.5%], p = 0.046). The total number of days having acute respiratory symptoms was significantly lower in the LF group (9.0) than in the placebo group (15.0, p = 0.030).Harms: The rate of adverse events was similar between the groups. No adverse drug reactions were found.Conclusions: LF intake decreased the prevalence of acute gastrointestinal symptoms in children aged 12–32 months.
Highlights
Despite remarkable advances in the improvement of child survival, the mortality rate of children in developing countries remains high
Breast milk is the ideal nourishment for the healthy growth and development of newborn infants; the World Health Organization (WHO) recommends that mothers breastfeed their children for up to 2 years of age or beyond [3]
The effects of LF-fortified formulas on children over 1 year of age are of interest, but have not yet been examined. This randomized, double-blind, placebo-controlled trial investigated the impact of an LF-fortified growing-up formula on acute gastrointestinal and respiratory symptoms in children aged 12–32 months
Summary
We investigated the effects of lactoferrin (LF)-fortified formula on acute gastrointestinal and respiratory symptoms in children. Intervention: Intake of placebo or LF (48 mg/day)-fortified formula for 13 weeks. Primary endpoint: Prevalence of acute gastrointestinal and respiratory symptom. Outcomes: The prevalence of acute gastrointestinal symptoms was significantly less in the LF group (22/53 [41.5%]) than in the placebo group (30/48 [62.5%], p = 0.046). The total number of days having acute respiratory symptoms was significantly lower in the LF group (9.0) than in the placebo group (15.0, p = 0.030). Harms: The rate of adverse events was similar between the groups. Conclusions: LF intake decreased the prevalence of acute gastrointestinal symptoms in children aged 12–32 months
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