Signs and Symptoms, RespiratoryNCT05492370
Effects of a Yeast Fermentate (EpiCor) Supplement on Cold or Flu Symptoms in Healthy Children
A study testing EpiCor in people with Signs and Symptoms, Respiratory, run by Cargill at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Signs and Symptoms, Respiratory
- What is being tested?
- EpiCor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteCanada
- Study dates
- 7 Sep 2022to 19 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- EpiCor, Placebo
- Medical subject headings
- Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiCorDietary supplement
2 gummies daily
PlaceboDietary supplement
2 gummies daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 84 days
Secondary outcomes (13)
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
Measured: 42 days
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.
Measured: At 42 and 84 days
Duration of cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Measured: At 42 and 84 days
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
Measured: At 42 and 84 days
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
Measured: At 42 and 84 days
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
Measured: At 42 and 84 days
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
Measured: At 42 and 84 days
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
Measured: At 42 and 84 days
Saliva secretory immunoglobulin A concentrations
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Measured: At 42 and 84 days
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.
Measured: At 42 and 84 days
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.
Measured: At 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.
Measured: At 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.
Measured: At 42 and 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start7 Sep 2022
- Primary completion18 Apr 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Signs and Symptoms, RespiratoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cargill
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492370
- Sponsor's protocol ID
- 21CLRFZ02
- Status last verified
- Nov 2023
- First submitted
- 29 Jul 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05492370
- Acronym / sponsor ID
- 21CLRFZ02
- Conditions
- Signs and Symptoms, Respiratory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- CargillIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EpiCor | Experimental | Dietary Supplement: EpiCor500 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTwo 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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpiCor2 gummies daily | Dietary supplement | EpiCor |
| Placebo2 gummies daily | Dietary supplement | Placebo |
Primary outcome
Incidence of cold or flu symptoms
Time frame: 84 days
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.
13 secondary outcomes
Incidence on cold or flu symptoms from baseline to day 42
Time frame: 42 days
Severity of cold or flu symptoms
Time frame: At 42 and 84 days
Duration of cold or flu symptoms
Time frame: At 42 and 84 days
Proportion of children with no cold or flu symptoms
Time frame: At 42 and 84 days
Number of days prior to first cold or flu symptoms
Time frame: At 42 and 84 days
Number of missed school or daycare days due to cold or flu symptoms
Time frame: At 42 and 84 days
Number of well days, related to the absence of cold or flu symptoms
Time frame: At 42 and 84 days
Use of prescription and non-prescription cold/flu medications to treat cold or flu symptoms
Time frame: At 42 and 84 days
Saliva secretory immunoglobulin A concentrations
Time frame: At 42 and 84 days
Quality of life as assessed by the KINDL questionnaire
Time frame: At 42 and 84 days
Safety profile as assessed by Adverse Events (AEs)
Time frame: At 42 and 84 days
Safety profile as assessed by vital sign blood pressure
Time frame: At 42 and 84 days
Safety profile as assessed by vital sign heart rate
Time frame: At 42 and 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, MD principal investigator
KGK Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EpiCor in people with Signs and Symptoms, Respiratory, run by Cargill at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cold or flu symptoms (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.