search
Back to results

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

Primary Purpose

Signs and Symptoms, Respiratory

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
EpiCor
Placebo
Sponsored by
Cargill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Signs and Symptoms, Respiratory

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • KGK Science Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EpiCor

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence on cold or flu symptoms from baseline to day 42
Determine the difference between EpiCor and placebo from baseline to day 42 on the incidence of cold or flu symptoms during an 84-day supplementation period
Severity of cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84, assessed of the individual items on CARIFS and by area under the curve (AUC) for the CARIFS daily symptom score. The CARIFS questionnaire includes 18 items answered on a 4-point scale (no problem = 0, minor problem = 1, moderate problem = 2, major problem = 3) across three domains (symptoms, function, and parental impact). The higher the score, the more sever the illness.
Duration of cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Proportion of children with no cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Number of days prior to first cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Number of missed school or daycare days due to cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Number of well days, related to the absence of cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Use of prescription and non-prescription cold/flu medications to treat cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Saliva secretory immunoglobulin A concentrations
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Quality of life as assessed by the KINDL questionnaire
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84. The KINDL questionnaire will be used to assess quality of life. This questionnaire contains 46 questions (scored 1-5; 1 - never, 2 - seldom, 3 - sometimes, 4 - often, 5 - all the time) answered by the caregiver.
Safety profile as assessed by Adverse Events (AEs)
To determine EpiCor safety profile in children aged 4-12 years as assessed by AEs for 42 and 84 days.
Safety profile as assessed by vital sign blood pressure
To determine EpiCor safety profile in children aged 4-12 years as assessed by blood pressure for 42 and 84 days.
Safety profile as assessed by vital sign heart rate
To determine EpiCor safety profile in children aged 4-12 years as assessed by heart rate for 42 and 84 days.

Full Information

First Posted
July 29, 2022
Last Updated
May 24, 2023
Sponsor
Cargill
Collaborators
KGK Science Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05492370
Brief Title
Effects of a Yeast Fermentate (EpiCor) Supplement on Cold or Flu Symptoms in Healthy Children
Official Title
Effects of a Yeast Fermentate (EpiCor) Supplement on Cold or Flu Symptoms in Healthy Children: A Randomized, Double-blind, Placebo Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
August 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cargill
Collaborators
KGK Science Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Signs and Symptoms, Respiratory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EpiCor
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
EpiCor
Intervention Description
2 gummies daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
2 gummies daily
Primary Outcome Measure Information:
Title
Incidence of cold or flu symptoms
Description
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.
Time Frame
84 days
Secondary Outcome Measure Information:
Title
Incidence on cold or flu symptoms from baseline to day 42
Description
Determine the difference between EpiCor and placebo from baseline to day 42 on the incidence of cold or flu symptoms during an 84-day supplementation period
Time Frame
42 days
Title
Severity of cold or flu symptoms
Description
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84, assessed of the individual items on CARIFS and by area under the curve (AUC) for the CARIFS daily symptom score. The CARIFS questionnaire includes 18 items answered on a 4-point scale (no problem = 0, minor problem = 1, moderate problem = 2, major problem = 3) across three domains (symptoms, function, and parental impact). The higher the score, the more sever the illness.
Time Frame
At 42 and 84 days
Title
Duration of cold or flu symptoms
Description
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time Frame
At 42 and 84 days
Title
Proportion of children with no cold or flu symptoms
Description
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time Frame
At 42 and 84 days
Title
Number of days prior to first cold or flu symptoms
Description
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time Frame
At 42 and 84 days
Title
Number of missed school or daycare days due to cold or flu symptoms
Description
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time Frame
At 42 and 84 days
Title
Number of well days, related to the absence of cold or flu symptoms
Description
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time Frame
At 42 and 84 days
Title
Use of prescription and non-prescription cold/flu medications to treat cold or flu symptoms
Description
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time Frame
At 42 and 84 days
Title
Saliva secretory immunoglobulin A concentrations
Description
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time Frame
At 42 and 84 days
Title
Quality of life as assessed by the KINDL questionnaire
Description
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84. The KINDL questionnaire will be used to assess quality of life. This questionnaire contains 46 questions (scored 1-5; 1 - never, 2 - seldom, 3 - sometimes, 4 - often, 5 - all the time) answered by the caregiver.
Time Frame
At 42 and 84 days
Title
Safety profile as assessed by Adverse Events (AEs)
Description
To determine EpiCor safety profile in children aged 4-12 years as assessed by AEs for 42 and 84 days.
Time Frame
At 42 and 84 days
Title
Safety profile as assessed by vital sign blood pressure
Description
To determine EpiCor safety profile in children aged 4-12 years as assessed by blood pressure for 42 and 84 days.
Time Frame
At 42 and 84 days
Title
Safety profile as assessed by vital sign heart rate
Description
To determine EpiCor safety profile in children aged 4-12 years as assessed by heart rate for 42 and 84 days.
Time Frame
At 42 and 84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Crowley, MD
Organizational Affiliation
KGK Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
KGK Science Inc
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5RB
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs