Baker’s Yeast Beta-Glucan Decreases Episodes of Common Childhood Illness In 1 to 4 Year Old Children during Cold Season in China.
H&J CRO International, Inc
Introduction: Infections, especially upper respiratory tract infections (URTI) are common in early childhood, which creates a large economic burden on both the healthcare system and individual family. There are many foods and dietary supplement ingredients intended to improve children’s health status and immune function to decrease their susceptibility to common childhood illness. The ability of bakers yeast beta glucan (BYBG) to reduce the number of episodes of common childhood illness in1 to 4 year old children was evaluated in a 12 week randomized, double-blinded, placebo controlled study conducted in China.
Methods: 174 subjects (12 to 48 months old) who had experienced at least two episodes of upper respiratory tract infection (URTI) in the previous three months were enrolled and randomized to two treatment groups (35 or 75 mg BYBG per day) or placebo. The primary study outcome was the proportion of subjects that did not experience any confirmed common childhood infectious illness episodes during the study. Secondary outcomes included number of episodes, and duration of both total infections and URTI.
Results: A total of 156 subjects (73 boys and 83 girls) completed the study and were included in full analysis set (FAS) statistical analysis. All relevant characteristics in the three groups were comparable. Children in the BYBG groups were significantly healthier during the study period than those in the placebo group. During the 12-week course of the study, 85% of children in the placebo group experienced one or more episodes of infectious illness. By contrast, there were only 47% and 32% children in BYBG treatment groups experienced infectious illness, significantly less than placebo group (p<0.001). The placebo group had significantly higher URTI incidence per child (p<0.0001) and more days with URTI symptoms (p< 0.0001) compared to either BYBG group. There were no statistically significant differences between the two BYBG treatment groups for either primary or secondary outcomes. All reported adverse events (AE) were mild to moderate and no serious adverse events (SAE) were reported during the study. Only 1 AE (mild vomiting) in the BYBG 35mg/d group was considered to have a doubtful relationship with the study product.
Conclusion: Bakers yeast β-glucan significantly decreased total episodes of common childhood infectious illness and episodes of URTI for children ages 12 to 48 months in a daycare setting. Both dosages of BYBG were well tolerated.