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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.

frontiers in pediatrics

Effects of Lactoferrin-Fortified Formula on Acute Gastrointestinal Symptoms in Children Aged 12–32 Months: A Randomized, Double-Blind, Placebo-Controlled Trial