NCT05492370

Effects of a Yeast Fermentate (EpiCor) Supplement on Cold or Flu Symptoms in Healthy Children

Effects of a Yeast Fermentate (EpiCor) Supplement on Cold or Flu Symptoms in Healthy Children: A Randomized, Double-blind, Placebo Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Cargill · Industry
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Accepted

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).

Conditions

• Signs and Symptoms, Respiratory

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	EpiCor	2 gummies daily
DIETARY_SUPPLEMENT	Placebo	2 gummies daily

Timeline

• Start date: 2022-09-07
• Primary completion: 2023-04-18
• Completion: 2023-07-19
• First posted: 2022-08-08
• Last updated: 2023-11-18

Locations

1 site across 1 country: Canada