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

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

256 Participants Needed

Trial Summary

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 safety data available for the treatment known as EpiCor, Placebo, Control, or Dummy Treatment?

Placebo treatments, often used as controls in clinical trials, have been studied for their safety and effectiveness across different diseases. However, reports on adverse events (unwanted side effects) in these trials are often incomplete or inconsistent, indicating a need for better reporting to fully understand their safety profile. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests if taking EpiCor daily for about three months can reduce cold or flu symptoms in children aged 4-12 who go to school or daycare. EpiCor is a supplement that may help boost the immune system.

Research Team

David Crowley, MD

Principal Investigator

KGK Science

Eligibility Criteria

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

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

Treatment Details

Interventions

• EpiCor
• Placebo

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Short-term effects of dry needling of thenar muscles in manual laborers with carpal tunnel syndrome: a pilot, randomized controlled study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. [2020]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

The mechanical effect of kinesiology tape on rounded shoulder posture in seated male workers: a single-blinded randomized controlled pilot study. [2022]