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. The ability of Wellmune® 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.

Study Protocol

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 Wellmune® 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

Children in the Wellmune® 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 Wellmune® 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 Wellmune® group.