Immunogenic Yeast-Based Fermentate for Cold/Flu-like Symptoms in Nonvaccinated Individuals

BACKGROUND: The common cold has a profound impact on employee attendance and productivity. Seasonal influenza is responsible for approximately 200,000 hospitalizations and 36,000 deaths per year in the United States alone. Over-the-counter medication efficacy has been questioned, and seasonal vaccination compliance issues abound. Our previously reported randomized trial of an oral fermentation product found an adjuvant benefit for vaccinated individuals in terms of a significantly reduced incidence and duration of cold and flu-like symptoms. METHODS: A concurrent 12-week, randomized, double-blind, placebo-controlled clinical trial of 116 subjects with no recent history of seasonal influenza vaccination was conducted. Participants received once-daily supplementation with 500 mg of a dried modified Saccharomyces cerevisiae oral fermentate (EpiCor) or placebo. Clinical outcome measurements included periodic interval-based in-clinic examinations and serologic analysis at baseline, 6 weeks, and 12 weeks. Participants utilized a standardized self-report symptom diary. RESULTS: Subjects receiving the intervention experienced a statistically significant reduction in the incidence (p = 0.01), a nonsignificant reduction in duration (p = 0.10), and no impact on the severity (p = 0.90) of colds or flu-like symptoms, but a more favorable safety profile compared with subjects receiving placebo. CONCLUSIONS: This nutritional-based fermentate appeared to be safe and efficacious in a unique at-risk population and should receive more clinical research as a potential method to reduce the incidence of cold and flu-like symptoms, in individuals with and without a history of influenza vaccination.