The two postbiotic strains developed by the firm, namely RHT3201 (Lacticaseibacillus rhamnosus IDCC 3201 tyndallizate) and BBR4401 (Bifidobacterium breve IDCC 4401 tyndallizate), are the only ones that have been approved by Korea’s Ministry of Food and Drug Safety (MFDS) to date.
“Both ingredients are still very new to Korean consumers, especially since the only postbiotics approved for use and are allowed to make functional claims are ours. Right now, we are trying our best to educate both consumers and our partners, although there’s still much to be done in spreading awareness.
“We’ve heard that many companies have been trying to get their postbiotics approved but haven’t been successful. Getting approval for functional ingredients, especially novel ones, in Korea is challenging. You have to back it up with lots of scientific evidence — the MFDS has specific guidelines on the requirements for clinical studies and results to be shown. Having more players enter the market could actually help us raise the awareness,” Yoona Kim from Ildong Bioscience’s B2B Sales told NutraIngredients-Asia.
Speaking to us at the recent Vitafoods Asia trade show in Bangkok, Kim added that one of the company’s efforts in raising awareness is through seminars at such events.
RHT3201 is used in its parent company Ildong Pharmaceutical’s gQlab Postbiotics RHT, a health functional food that claims to benefit intestinal health and skin immunity.
The firm is also actively seeking partnerships with other companies for application of its postbiotics, as well as export opportunities.
“We have been trying to export both RHT3201 and BBR4401, but as EpiCor is so well-known in the US, it’s hard to beat its position in the market. It has undergone so many clinical trials, while ours has only gone through one. Nevertheless, we are carrying out a study focusing on gut health, and we expect to reach a conclusion by the end of this year, with publication of the paper in early 2025.
“In addition, we are working on registering these two ingredients to Malaysia’s National Pharmaceutical Regulatory Agency (NPRA). If everything goes smoothly, we hope to complete the registration early next year and launch in the market.”
At the same time, Ildong looks to continue building its portfolio of probiotic strains and supporting them with clinical studies.
“In Korea, the general health claim that we can make for probiotics hasn’t been an issue. But when expanding overseas, customers tend to ask for clinical evidence, even for general health claims. That is why we are working to back our probiotics with more science, and in the meantime, hopefully our postbiotics would take off, too.”
Clinically proven
A randomised, double-blind, placebo-controlled study involving 66 children with moderate atopic dermatitis (AD) was conducted in 2020 to evaluate the effect of RHT3201 in improving skin immunity.
The children, aged between one and 12 years, orally consumed either RHT3201 at a dose of 1.0 × 1010 CPU/d or a placebo for 12 weeks.
The results were analysed based on changes in SCORAD (SCORing Atopic Dermatitis), a clinical tool to assess the extent and severity of eczema and AD.
It was found that the change in SCORAD total score at 12 weeks from baseline was significantly greater in the RHT3201 group, compared to the control group.
There was also improvement in allergic inflammatory blood biomarkers.
Specifically, levels of eosinophil cationic protein (ECP) and interleukin (IL)-31 showed tendency to decrease in the RHT3201 group. The decrease was more remarkable in the subgroup analysis in AD for more than 50 months.
As for BBR4401, a paper published in Fermentation last August indicated that the postbiotic helped improve cholesterol levels, with the efficacy shown at just four weeks.
The study included 66 adult participants with low-density lipoprotein-cholesterol (LDL-C) levels between 100mg/dL and 150mg/dL.
For 12 weeks, two intervention groups were given 1 × 1010 (low-dose) and 1 × 1011 CFU (high-dose), and a placebo group consumed 97% w/w of maltodextrin daily.
Based on mean changes from baseline, there was significant reduction in LDL-C in the low-dosage group at week 12, while results were significant in the high-dosage group by week 4.
ApolipoproteinB is a protein involved in the metabolism of lipids that has been suggested in past studies to be a more accurate indicator of cardiovascular risk than total cholesterol or LDL-C.
Notably, there was a significant decrease in apolipoproteinB levels in both intervention groups after 12 weeks.