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Introduction

These randomized double-blind placebo-controlled human clinical trials examined the effects of EpiCor^® postbiotic on the incidence and duration of cold and flu symptoms on non-flu vaccinated and flu-vaccinated subjects.

Flu-Vaccinated Trial: Key Findings

• Cold and flu-like symptom clinical occurrences, as recorded by subjects, were significantly lower with EpiCor^® postbiotic vs placebo over 12 weeks (1.26 vs 1.42 days; p=0.011).

• Duration of cold and flu-like symptoms were significantly lower by 17% with EpiCor^® postbiotic vs placebo (4.16 vs 5.01 days; p=0.028).

• Reduced symptoms of hoarseness, nasal stuffiness, and duration of feelings of weakness with EpiCor^® postbiotic vs placebo (p=0.008).

Non Flu-Vaccinated Trial: Key Findings

• Cold and flu symptoms clinical occurrences, as recorded by subjects, were significantly lower with EpiCor^® postbiotic vs placebo over 12 weeks (1.32 vs 1.5 days; p=0.01).

• There were no significant reductions in duration or severity of symptoms between intervention and placebo.

METHOD

Flu-Vaccinated Trial: This was a 12-week trial conducted during the cold and flu season: December 2006 through March 2007. The subjects were 130 healthy adults, ages 18-76 (mean 44 ± 11), who had been vaccinated against that season’s influenza virus. 116 subjects finished the trial with 52 taking 500 mg/day EpiCor^® postbiotic and 64 taking placebo.

Non Flu-Vaccinated Trial: This was a 12-week randomized, double-blind, placebo-controlled trial conducted during the cold and flu season: January through March. The subjects had not been vaccinated against that season’s influenza virus. 116 healthy adult subjects were enrolled in the trial 58 (mean age 37.1) taking 500 mg/day EpiCor^® postbiotic and 58 (mean age 39.6) taking placebo. There were two dropouts in the EpiCor^® postbiotic group and one dropout in the placebo group due to lack of clinical protocol compliance.

In both trials, the recording of common cold or influenza-like symptoms was primarily based on self-report diaries. The following symptoms were self-assessed on a 0-10 point scale for severity (0 = no symptom; 10 = most severe): headache, general aches and pains, fatigue, weakness, nasal stiffness, nasal drainage, sore throat, cough, hoarseness, chest discomfort and chills; any fever, including the temperature, was also recorded. Incidence, duration and severity of these symptoms can be used to clinically define either a common cold or influenza infection (Center for Disease Control and Prevention, 2007).

Incidence of symptoms was defined as the number of clinical occurrences self-reported during the entire 12-week study period. Duration of symptoms was defined as the number of consecutive illness days.

results

conclusion

Summary of two clinical trials: