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

We investigated the effects of lactoferrin (LF)-fortified formula on acute gastrointestinal and respiratory symptoms in children. Randomized, double-blind, placebo-controlled trial. Children aged 12-32 months in Japan. Intake of placebo or LF (48 mg/day)-fortified formula for 13 weeks. Prevalence of acute gastrointestinal and respiratory symptom. 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, = 48; LF group, = 53). 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%], = 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, = 0.030). The rate of adverse events was similar between the groups. No adverse drug reactions were found. LF intake decreased the prevalence of acute gastrointestinal symptoms in children aged 12-32 months.