Effects of Lactoferrin on Prevention of Acute Gastrointestinal Symptoms in Winter: A Randomized, Double-Blinded, Placebo-Controlled Trial for Staff of Kindergartens and Nursery Schools in Japan.

Masaru Mizuki,Hirotsugu Oda,Teruomi Tsukahara,Fumiaki Abe,Miyuki Tanaka,Tetsuo Nomiyama,Koji Yamauchi

doi:10.3390/ijerph17249582

Abstract

This study investigated the preventive effects of lactoferrin (LF) on subjective acute gastrointestinal symptoms during the winter in a randomized, double-blinded, placebo-controlled parallel-group comparative trial. The eligible subjects were healthy adults working at kindergartens and nursery schools. We randomized the subjects to the Placebo group (0 mg/day), the Low LF group (200 mg/day), and the High LF group (600 mg/day) for 12 weeks. The prevalence of acute gastrointestinal symptoms was significantly lower in the High LF (13/112 vs. 26/116; p = 0.030) and the Low LF (13/107 vs. 26/116; p = 0.040) groups than in the Placebo group. The adjusted odds ratio for the prevalence of acute gastrointestinal symptoms was 2.78 (95% CI: 1.19–6.47) in the Placebo group compared with the High LF group. LF is useful to prevent acute gastrointestinal symptoms among childcare workers, who mainly consist of women.

Highlights

Infectious diseases such as infectious gastroenteritis are prevalent in the winter, and the prevention of these diseases is a public health issue in Japan [1,2,3]
A full analysis set (FAS) of the data of 335 subjects was used in the intervention period for the primary analyses (Figure S1)
The cumulative prevalence days of abdominal pain, nausea, diarrhea, and fever showed a significant trend, and those of abdominal pain, diarrhea, and fever were significantly fewer in the High LF group and Low LF group than in the Placebo group

Summary

Introduction

Infectious diseases such as infectious gastroenteritis are prevalent in the winter, and the prevention of these diseases is a public health issue in Japan [1,2,3]. Childcare workers have a high risk of infection in the same environment. These infectious diseases are mainly caused by viruses. Noroviruses are a leading cause of infectious gastroenteritis in the winter, and rotaviruses, sapoviruses, and astroviruses can cause gastroenteritis [8]. Infectious gastroenteritis is a contagious disease across all age groups, and it causes symptoms such as fever, abdominal pain, nausea, vomiting, and diarrhea [9]. As the genome of noroviruses mutates, no vaccines are currently available [10]

Methods

Results

Conclusion