Effects of a Yeast Fermentate (EpiCor) Supplement on Cold or Flu Symptoms in Healthy Children
Condition: Signs and Symptoms, Respiratory
MeSH terms: Signs and Symptoms, Respiratory
Study type: Interventional

Summary: 
      This is a double-blind, randomized, placebo-controlled study. The purpose of the clinical
      study is to determine the difference between 84 days of once daily oral EpiCor
      supplementation compared to placebo on the incidence of cold or flu symptoms among children
      aged 4-12 years who are attending school or daycare.
    

Detailed description: 
      This double-blind, randomized, placebo-controlled study aims to determine the difference
      between 84 days of once daily oral EpiCor supplementation compared to placebo on the
      incidence of cold or flu symptoms among children aged 4-12 years who are attending school or
      daycare. Healthy children, with parental consent, are included in the study. The study
      includes one screening visit (day -45 to -15), a run-in period (day -14 to -1), and 3
      clinical visits: day 0 (baseline), day 42, and day 84 (end of study). During the screening
      visit, the investigator reviews medical history, concomitant therapies, current health
      status, assesses inclusion and exclusion criteria, vital signs, weight and height
      measurements, assesses pre-emergent adverse events, and dispenses saliva collection kit for
      salivary Immunoglobulin A (IgA) analysis as well as study dairy and Canadian Acute
      Respiratory Illness and Flu Scale (CARIFS) questionnaire. Participants complete the CARIFS
      questionnaire and study dairy during the run-in period. On day 0, participants return to the
      clinic with their saliva collecting kit, completed study diaries, and CARIFS questionnaire
      for baseline assessments; during this visit, eligible participants are randomized and they
      are also instructed to initiate investigational product administration on the morning of day
      1. At day 42, participants and their caregivers return to the clinic for assessments with
      unused investigation product, saliva collection kit, completed study diaries, CARIFS
      questionnaire, and a Questionnaire for measuring health-related Quality of Life in Children
      and Adolescents (KINDL); investigator reviews concomitant therapies and adverse events,
      dispenses new study diary, CARIFS questionnaire, saliva collection kit, investigational
      product, and measures vital signs, weight, and height. The same procedure is repeated during
      the last clinical visit at day 84 (end of study), except that no investigational product is
      provided. Daily throughout the study, participant caregivers complete the study diary to
      track missed school or daycare days, well days, use of prescription/non-prescription cold/flu
      medication, adverse events, and concomitant therapies, and cold or flu symptoms (via CARIFS
      questionnaire when cold or flu symptoms are present).
    

Intervention name(s): EpiCor; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 gummies daily; 2 gummies daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment