EpiCor

About this trial

Last updated 6 years ago

Study ID

EpiCor

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

1 to 6 Years

All

Trial Timing

Ended 6 years ago

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.

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

Compare Effects of EpiCor and Vitamin C to Vitamin C Alone on the Common Cold or Influenza in Healthy Children