EpiCor for Respiratory Symptoms

Overseen By Malkanthi Evans, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Cargill

Must not be taking: Immunosuppressants, Allergy shots

Disqualifiers: Pregnancy, Cancer, Asthma, others

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a daily gummy supplement called EpiCor can reduce cold or flu symptoms in children. It is a randomized study, so some children will receive EpiCor gummies, while others will receive placebo gummies, which look the same but contain no active ingredient. The trial is open to healthy children aged 4-12 who attend school or daycare and can maintain their usual routines. As an unphased trial, participation offers an opportunity to contribute to research that could enhance children's health.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications, but it asks participants to maintain their current lifestyle habits, including medications, as much as possible.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that EpiCor, the treatment being tested in this study, has been safe in previous tests. The safety information for EpiCor indicates that no special precautions are needed when handling it, suggesting it is well-tolerated. Available documents report no major side effects.

This study is labeled "Not Applicable" for clinical trial phases, which usually means the treatment has been used safely outside strict clinical settings. This can provide some reassurance about its safety for human use.

As always, discussing any concerns with a healthcare provider before joining a trial is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard cold and flu treatments that mainly address symptoms, EpiCor is unique because it is derived from a yeast fermentate, which may boost the immune system. Researchers are excited about this treatment because its active ingredient, EpiCor, is a natural supplement that could reduce the frequency and severity of colds and flu in children by enhancing immune function. Most traditional treatments focus on alleviating symptoms after they appear, but EpiCor has the potential to proactively strengthen the body’s defenses, offering a preventive approach.

What evidence suggests that EpiCor might be an effective treatment for cold or flu symptoms in children?

Research shows that EpiCor, a type of yeast product, might help lessen cold and flu symptoms in children. In this trial, participants will receive either EpiCor or a placebo. Studies have found that children who took EpiCor experienced milder symptoms and needed less medicine than those who took a placebo, a harmless pill with no active ingredients. One study discovered that EpiCor could reduce the chance of getting cold and flu symptoms by 21%. Another study showed it might support the immune health of younger people. These findings suggest EpiCor could be a good option for boosting children's immune systems and reducing the effects of colds and flu. ^{6 7 8 9 10}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science

Are You a Good Fit for This Trial?

Inclusion Criteria

The child and the child's parent(s) or legal guardian(s) have given voluntary, written, informed consent to partake in the study

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

Exclusion Criteria

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

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Run-in

Participants complete the CARIFS questionnaire and study diary during the run-in period

2 weeks

No visits

Treatment

Participants receive daily oral EpiCor or placebo supplementation for 84 days

12 weeks

3 visits (in-person) at day 0, day 42, and day 84

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EpiCor
• Placebo

How Is the Trial Designed?

Group I: EpiCor Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Cargill

Lead Sponsor

Trials

28

Recruited

3,200+

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Published Research Related to This Trial

A systematic review of 80 randomized controlled trials (RCTs) on noninvasive analgesic treatments revealed that adverse event (AE) reporting was often incomplete, with over 40% of trials not reporting any serious adverse events.

The review highlighted that trials involving participants with pain conditions and those sponsored by industry provided better AE data, indicating a need for improved consistency and thoroughness in AE reporting across all analgesic RCTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. Smith, SM., Wang, AT., Katz, NP., et al.[2023]

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

The study systematically analyzed placebo effects from randomized, placebo-controlled trials, revealing that while placebos can influence clinical symptoms, they do not affect laboratory values like blood glucose in diabetics.

Placebo side effects were found to be similar to those of active treatments, highlighting the importance of careful placebo use in clinical research to ensure patient safety and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. Weihrauch, TR.[2019]

Citations

1. cargill.com cargill.com/2024/epicor-postbiotic-shown-to-help-support-childrens-immune

EpiCor® postbiotic shown to help support children's ... “The statistically significant positive results of this study affirm EpiCor may help support immune health in younger populations and ...

2. nature.com nature.com/articles/s41390-024-03331-z

Efficacy of a yeast postbiotic on cold/flu symptoms in ... EpiCor supplementation resulted in significantly lower cold/flu symptom severity and less cold/flu medication usage than Placebo demonstrating a beneficial ...

3. nutraingredients.com nutraingredients.com/Article/2008/02/27/clinical-trial-boosts-epicor-s-efficacy-for-immune-health/

Clinical trial boosts EpiCor's efficacy for immune health Supplementation with a yeast fermentate can boost the immune system and reduce the occurrence of cold and flu symptoms by 21 per cent, according to the results ...

4. nutritionaloutlook.com nutritionaloutlook.com/view/epicor-may-support-immune-health-in-children-according-to-recently-published-study

EpiCor may support immune health in children according ... Results showed that children taking a gummy supplement containing EpiCor saw significantly less symptom severity when they contracted the cold ...

5. vitaminretailer.com vitaminretailer.com/epicor-shown-to-help-support-childrens-immune-health/

EpiCor Shown to Help Support Children's Immune Health “The statistically significant positive results of this study affirm EpiCor may help support immune health in younger populations and upholds ...

6. epicor.com epicor.com/en-us/solutions/industries/distribution/safety-supply-distribution-software/

Safety Supply Distribution Software Manage product information like safety data sheets and usage instructions. Fire and Rescue Safety Gear Suppliers. Track and manage maintenance schedules and ...

7. epiusers.help epiusers.help/t/epicor-chemical-msds/125426

Epicor & Chemical MSDS - Kinetic ERP We just store the MSDS number on the part. we added a few other UD fields to store critical safety info if needed. we have a dashboard that ...

8. youtube.com youtube.com/watch?v=ITunfyn-H9U

How To Calculate Min Max Safety in Epicor ERP In this tutorial, you'll explore the powerful Min Max Safety Workbench in Epicor with a step-by-step walkthrough on how to review and update ...

9. nasc.cc nasc.cc/wp-content/uploads/2021/07/EpiCor-SDS.pdf

SAFETY DATA SHEET Person-related Safety Precautions: Not required. Measures for Cleaning/Collecting: Conventional clean up. Measures for Environmental Protection: Not required.

10. epicor.com epicor.com/en-us/resources/customer-events/protecting-customer-credit-card-data/

Protecting Customer Credit Card Data Learn how credit card tokenization helps prevent data breaches and keeps customer payment info secure in this essential webinar on card-on-file risks.