Compare Effects of EpiCor and Vitamin C to Vitamin C Alone on the Common Cold or Influenza in Healthy Children
Compare Effects of EpiCor and Vitamin C to Vitamin C Alone on the Common Cold or Influenza in Healthy Children
The purpose of the clinical study is to evaluate efficacy of regular daily, 12 weeks,
 consumption of EpiCor syrup containing EpiCor and vitamin C in non-vaccinated children 1-6
 years old on preventing episodes of the common cold and flu as well as on the severity of
 symptoms of the common cold and flu in case of their occurrence. Additionally, the study aims
 to assess the effect of EpiCor on the use of prescription drugs and changes of a selected
 biochemical marker. This is a double-blind, randomized, controlled multi-center clinical
 trial.
This is a double-blind, randomized, controlled multi-center clinical trial aiming to evaluate
 the effects of daily consumption of EpiCor with vitamin C, primarily on the incidence and,
 secondary, on the duration and severity of the common cold and influenza in children,
 compared to the effects of daily consumption of vitamin C alone. Healthy children aged 1-6
 years old are included in the study after parents have provided informed consent for study
 participation. Children are divided in 3 age groups (1-2 year old, 3-4 years old, 5-6 years
 old) and randomized in one of the two groups (intervention or control) at a 1:1 ratio.
 Children eligible for participation are included in the study for 12 weeks. During this
 period, they visit the investigational center 3 times. During visit 1 (day 0) caregivers get
 familiarized with the purpose, course and procedures of the trial, provide written informed
 consent upon which investigator assesses child's suitability for participation and, for
 eligible children, a study participant number is provided and a randomization number is
 assigned; in addition, the investigator collects demographic information, data on vital
 signs, medical history, collects a sample for determination of salivary secretory
 immunoglobulin A (sIgA), provides caregivers with a Study Dairy and clear instructions
 regarding completion, consumption, storage and return of unused syrup, taking medication and
 other food supplements during the study, monitoring adverse events and measures to be taken
 in the event of serious adverse events, determines the daily dose of syrup to be taken based
 on child's age, supplies the caregiver with enough syrup and sets a date for next visit.
 Between visits, children take a prescribed dose of syrup once daily. Six weeks (visit 2) and
 12 weeks (visit 3) after the first visit, children and caregivers visit the investigational
 center again. During these 2 visits, the investigator collects data on vital signs, reviews
 concomitant medication and the taking of other food supplements, collects sample for
 determination of salivary SIgA, reviews the Study Dairy, supplies the caregiver with new
 syrup and provides the same clear instructions as in visit 1. Caregivers are asked to
 complete the Study Dairy on daily basis and, each time a caregiver marks that a symptom is
 present, the Investigator receives a notification and reviews the symptoms and consequently
 confirms the episode of a common cold/flu. The Canadian Acute Respiratory Illness and Flu
 Scale (CARIFS) is used to assess the severity of symptoms of the common cold and flu in
 participating children and, in case of occurrence of cold/flu symptoms, caregivers are asked
 to complete the form twice a day for the first seven days, once on day 10 and once on day 14.
Inclusion Criteria:

 -  Generally healthy male and female children

 -  1-6 years of age

 -  Children attending kindergarten

 -  Signed informed consent by child's parent or legal guardian and willingness to
 participate in all study activities

 Exclusion Criteria:

 -  Immune dysfunction and/or taking an immunosuppressive medication

 -  Child who has received flu vaccination

 -  Child who is still breastfed

 -  Child taking other food supplements

 -  Unable or unwilling to comply with study protocol, including ingesting investigational
 product, and completing subject dairy

 -  Current participation in another clinical study

 -  Severe co-morbidity or concomitant disease

 -  Concurrent disease or condition, which in the judgment of the investigator, would make
 the child inappropriate for participation in the study

 -  High risk of complications from influenza

 -  Allergies to yeast-derived products

 -  Severe environmental allergies requiring medication or need for allergy shots