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

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.