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

NCT05492370 | Completed

• 1 other identifier: 21CLRFZ02
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Signs and Symptoms, Respiratory

Outcome Measures

Primary Outcomes (1)

• Incidence of cold or flu symptoms

  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.

  84 days

Secondary Outcomes (13)

• Incidence on cold or flu symptoms from baseline to day 42

  42 days

• Severity of cold or flu symptoms

  At 42 and 84 days

• Duration of cold or flu symptoms

  At 42 and 84 days

• Proportion of children with no cold or flu symptoms

  At 42 and 84 days

• Number of days prior to first cold or flu symptoms

  At 42 and 84 days

Study Arms (2)

EpiCor

EXPERIMENTAL

500 mg EpiCor given as two gummy supplements. Participants will be instructed to take two gummies per day in the morning, with or without food, for 84 days, starting on Day 1.

Dietary Supplement: EpiCor

Placebo

PLACEBO COMPARATOR

Two gummy supplements. Participants will be instructed to take two gummies per day in the morning, with or without food, for 84 days, starting on Day 1.

Dietary Supplement: Placebo

Interventions

EpiCor DIETARY_SUPPLEMENT

2 gummies daily

EpiCor

Placebo DIETARY_SUPPLEMENT

2 gummies daily

Placebo

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Males and females between the age of 4-12 years of age, inclusive
• Individuals of child-bearing potential must have a negative baseline urine pregnancy test
• Enrolled in and attending school or daycare at baseline
• Healthy as determined by medical history and review of health status as per Qualified Investigator
• Agrees to maintain current lifestyle habits as much as possible throughout the study depending on their ability to maintain the following: diet, medications, supplements, exercise, and sleep and avoid taking new supplements
• Willing to complete evaluations, measurements, questionnaires, diaries, and tests associated with each clinic visit and be compliant to study product intake throughout the study
• A care provider who can reliably bring the participant to all study visits; the participant's primary caregiver must be willing and able to complete the questionnaires
• The child and the child's parent(s) or legal guardian(s) have given voluntary, written, informed consent to partake in the study

You may not qualify if:

• Individuals who are pregnant
• Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
• History or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal condition which affects absorption, or pancreatic disorders, as assessed by the Qualified Investigator
• Immune dysfunction and/or taking an immunosuppressive medication
• Severe environmental allergies requiring medication or need for allergy shots
• Cancer. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
• Asthma, as assessed by the Qualified Investigator
• Participants with siblings that live in the same household and are eligible for the study unless they are enrolled consecutively (e.g., not enrolled at the same time)
• Participation in a clinical research trial within 30 days prior to randomization, as assessed by the Qualified Investigator
• Participant or participant's caregiver who are cognitively or neurodevelopmentally impaired and/or are unable to give informed consent
• Any other condition that may adversely affect the ability to complete the study or its measures or which may pose significant risk to the participant as assessed by the Qualified Investigator

Sponsors & Collaborators

• Cargill: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc

London, Ontario, N6A 5RB, Canada

Location

MeSH Terms

Conditions

Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Crowley, MD

  KGK Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 8, 2022
• Study Start: September 7, 2022
• Primary Completion: April 18, 2023
• Study Completion: July 19, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CA (1)