AUTHOR=Motoki Noriko , Mizuki Masaru , Tsukahara Teruomi , Miyakawa Momoko , Kubo Shutaro , Oda Hirotsugu , Tanaka Miyuki , Yamauchi Koji , Abe Fumiaki , Nomiyama Tetsuo 

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

JOURNAL=Frontiers in Pediatrics

VOLUME=8

YEAR=2020

URL=https://www.frontiersin.org/journals/pediatrics/articles/10.3389/fped.2020.00233

DOI=10.3389/fped.2020.00233

ISSN=2296-2360

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