Writing in Pediatric Research, a Nature journal, the scientists reported that 12 weeks of supplementation was also associated with a reduced severity of sore throat and muscle aches or pains.
“This is the first clinical study in a pediatric population demonstrating efficacy of a postbiotic delivered in a gummy format. Nutraceuticals in a gummy format are especially important in children’s supplements because this population is less likely to tolerate more classical delivery forms such as capsules or tablets,” wrote the researchers.
Naïve immune systems
Speaking with NutraIngredients-USA, Dr. Justin Green, Director of Scientific Affairs for EpiCor - A Cargill Brand and a co-author on the new paper, explained that the new study builds on earlier randomized controlled trials (RCTs) with EpiCor in adults that found a reduction in various parameters of cold and flu.
In addition to the potential immune benefits, Cargill has also expanded its understanding of EpiCor, a postbiotic derived from yeast fermentate, with model and clinical studies on the postbiotic’s gut health benefits.
Adding to the significance of the new results is the moment in time when the study was performed.
“The study was performed during the 2022-23 flu season, which was predicted to be hard on this pediatric population,” explained Dr. Mal Evans, KGK’s Chief Science Officer.
Indeed, the US Centers for Disease Control and Prevention (CDC) classified the 2022-23 flu season as “high severity,” and it was noteworthy that it began earlier than previous seasons. Measures to control the COVID 19 pandemic meant that many children had lived through extended periods of isolation and increased hygiene measures, making them even more immunologically naïve than normal.
“It is remarkable that EpiCor postbiotic was proved to be efficacious during this particular flu season,” said Dr. Evans. “I think the results from a scientific point of view are very noteworthy.”
Study details
The new study included 256 children aged between 4 and 12 who were attending school and/or daycare. The children were randomly assigned to receive gummies formulated with or without either 500 mg per day of EpiCor for 12 weeks during the 2022–2023 flu season in Ontario.
The study used the Canadian Acute Respiratory Illness and Flu Scale (CARIFS), a validated tool that was developed specifically for pediatric studies, explained Dr. Evans. Each group had over 100 participants, making it a very robust study population, she said.
Dr. Green added that 17 of the 18 measures in the CARIFS survey numerically improved over the 12-week study, with improvements in the total severity score reaching statistical significance, while ‘sore throat’ and ‘muscle aches or pains’ symptom scores also decreased significantly, compared to placebo.
“These kids hadn’t seen many viruses at this time [because of the pandemic],” said Dr. Green. “And we found that EpiCor helped to keep the severity down.”
Another interesting result was the reduction in use of over the counter (OTC) measures, said Dr. Green, with the placebo group found to be 1.73 times more likely to use cold/flu medication, compared to EpiCor group.
“Importantly, supplementation with EpiCor was found to be safe and well tolerated in the studied population, strengthening previous safety findings,” wrote the researchers in the paper.
“The combination of efficacy and safety findings from the current study suggest that EpiCor supplementation may allow caregivers to reduce the cold/flu medication provided to their child while also mitigating the severity of symptoms.”
Stability and clinical benefits
Growth in children’s supplements has outpaced growth in the adult space, noted Dr. Green, and the study’s choice to use a gummy format provided validation that such a format produces very high rates of compliance (97% in this study), and the ingredient still has clinical benefits after being subjected to a gummy manufacturing process.
Prior to publication, Dr. Green presented the findings at the IPA World Congress + Probiota Americas, hosted by NutraIngredients-USA.
“We’re absolutely talking to a lot of different customers about this study,” he said, “as well as gummy manufacturers. The study shows the promise of this postbiotic to remain stable and still have clinical benefits.”
Source: Pediatric Research
2024, published online ahead of print, doi: 10.1038/s41390-024-03331-z
“Efficacy of a yeast postbiotic on cold/flu symptoms in healthy children: A randomized-controlled trial”
Authors: R.G. Singh, V. Garcia-Campayo, J.B. Green, et al.
