10.3389/fped.2020.00233.s001 Noriko Motoki Noriko Motoki Masaru Mizuki Masaru Mizuki Teruomi Tsukahara Teruomi Tsukahara Momoko Miyakawa Momoko Miyakawa Shutaro Kubo Shutaro Kubo Hirotsugu Oda Hirotsugu Oda Miyuki Tanaka Miyuki Tanaka Koji Yamauchi Koji Yamauchi Fumiaki Abe Fumiaki Abe Tetsuo Nomiyama Tetsuo Nomiyama Data_Sheet_1_Effects of Lactoferrin-Fortified Formula on Acute Gastrointestinal Symptoms in Children Aged 12–32 Months: A Randomized, Double-Blind, Placebo-Controlled Trial.docx Frontiers 2020 lactoferrin infectious disease diarrhea growing-up formula children 2020-05-19 13:05:54 Dataset https://frontiersin.figshare.com/articles/dataset/Data_Sheet_1_Effects_of_Lactoferrin-Fortified_Formula_on_Acute_Gastrointestinal_Symptoms_in_Children_Aged_12_32_Months_A_Randomized_Double-Blind_Placebo-Controlled_Trial_docx/12327704 <p>Objective: We investigated the effects of lactoferrin (LF)-fortified formula on acute gastrointestinal and respiratory symptoms in children.</p><p>Design: Randomized, double-blind, placebo-controlled trial.</p><p>Setting and subjects: Children aged 12–32 months in Japan.</p><p>Intervention: Intake of placebo or LF (48 mg/day)-fortified formula for 13 weeks.</p><p>Primary endpoint: Prevalence of acute gastrointestinal and respiratory symptom.</p><p>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).</p><p>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).</p><p>Harms: The rate of adverse events was similar between the groups. No adverse drug reactions were found.</p><p>Conclusions: LF intake decreased the prevalence of acute gastrointestinal symptoms in children aged 12–32 months.</p>