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

Abstract

<b>Objective:</b> We investigated the effects of lactoferrin (LF)-fortified formula on acute gastrointestinal and respiratory symptoms in children. <b>Design:</b> Randomized, double-blind, placebo-controlled trial. <b>Setting and subjects:</b> Children aged 12-32 months in Japan. <b>Intervention:</b> Intake of placebo or LF (48 mg/day)-fortified formula for 13 weeks. <b>Primary endpoint:</b> Prevalence of acute gastrointestinal and respiratory symptom. <b>Results:</b> 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, <i>n</i> = 48; LF group, <i>n</i> = 53). <b>Outcomes:</b> 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%], <i>p</i> = 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, <i>p</i> = 0.030). <b>Harms:</b> The rate of adverse events was similar between the groups. No adverse drug reactions were found. <b>Conclusions:</b> LF intake decreased the prevalence of acute gastrointestinal symptoms in children aged 12-32 months.