1. Efficacy of a yeast postbiotic on cold/flu symptoms in healthy children: A randomized-controlled trial.
- Author
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Singh RG, Garcia-Campayo V, Green JB, Paton N, Saunders JD, Al-Wahsh H, Crowley DC, Lewis ED, Evans M, and Moulin M
- Subjects
- Humans, Child, Female, Male, Child, Preschool, Ontario, Treatment Outcome, Double-Blind Method, Probiotics therapeutic use, Probiotics administration & dosage, Severity of Illness Index, Saccharomyces cerevisiae, Common Cold drug therapy, Influenza, Human prevention & control
- Abstract
Background: Children attending school/daycare are at high risk of acute respiratory tract infections. EpiCor
TM postbiotic, derived from yeast fermentate, has been demonstrated to improve immune function in adults, reducing the incidence of cold/flu-like or allergy symptoms. As such, studies are warranted in children as available pharmaceutical options have unwanted side effects., Methods: Two-hundred and fifty-six children aged 4-12 years attending school/daycare were randomized to either EpiCor or Placebo for 84 days during the 2022-2023 flu season in Ontario, Canada. The Canadian Acute Respiratory Illness and Flu Scale (CARIFS) and study diary assessed the incidence and severity of cold/flu symptoms and the use of cold/flu medications. Adverse events were recorded., Results: Total CARIFS severity scores, 'sore throat' and 'muscle aches or pains' symptom scores in the EpiCor group were significantly lower compared to Placebo during incidences of cold/flu (P ≤ 0.05). Participants taking Placebo were 1.73 times more likely to use cold/flu medication compared to those receiving EpiCor (P = 0.04). The incidence of cold/flu symptoms was not significantly different between groups. EpiCor was found to be safe and well-tolerated., Conclusions: EpiCor supplementation resulted in significantly lower cold/flu symptom severity and less cold/flu medication usage than Placebo demonstrating a beneficial effect on immune function in children., Impact: Children are at high risk of acquiring cold/flu infections and safe and efficacious mitigating regimens are lacking. Children supplemented daily with 500 mg EpiCorTM postbiotic derived from yeast fermentate had significantly lower overall cold/flu symptom severity, and severity of sore throat and muscle aches or pains over the 84-day supplementation period. EpiCor supplementation resulted in decreased use of traditional cold/flu medication. Daily supplementation with 500 mg of EpiCor for 84 days was safe and well tolerated by healthy children aged 4-12 years attending school or daycare., Competing Interests: Competing interests: V.G.C, J.G, N.P, J.D.S. are employees of Cargill Limited c/o Cargill Inc., R.S, M.M, D.C.C, H.A, E.D.L are employees of KGK Science Inc., M.E is a faculty member at Western University. All authors declare no competing interests. Ethical and regulatory approval: This randomized, double-blind, placebo-controlled, parallel study was conducted at KGK Science Inc. (London, Ontario, Canada) from September 2022 to April 2023. The study was reviewed by the Natural and Non-Prescription Health Products Directorate (NNHPD), Health Canada, Ottawa, Ontario and approved on March 03, 2022. Ethics approval was granted on June 17, 2022, by the Institutional Review Board Services (Aurora, Ontario, Canada; Pro00063328). The trial followed CONSORT guidelines for randomized controlled trials20 (Supplementary Table 2) and written informed consent was obtained from all participants prior to the initiation of any study procedures. The study was registered with Clinicaltrials.gov (NCT05492370). Informed consent: Each participant and their parent(s) or legal guardian gave written informed consent to participate in the study., (© 2024. The Author(s).)- Published
- 2024
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