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

Frontiers in Pediatrics

article

Noriko Motoki¹  Tetsuo Nomiyama¹  Masaru Mizuki¹  Teruomi Tsukahara¹  Momoko Miyakawa²  Shutaro Kubo²  Hirotsugu Oda²  Miyuki Tanaka²  Koji Yamauchi²  Fumiaki Abe² 

[1] Department of Preventive Medicine and Public Health, Shinshu University School of Medicine;Food Ingredients and Technology Institute, R&D Division, Ltd.

关键词: lactoferrin;    infectious disease;    diarrhea;    growing-up formula;    children;   

DOI  :  10.3389/fped.2020.00233

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 摘 要 】

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.

【 授权许可】

CC BY