Oral, skin and cognition research: Korean probiotics firm Bifido kickstarts series of local and overseas clinical trials

By Tingmin Koe contact

- Last updated on GMT

By modulating the gut microbiome, South Korean firm Bifido INC believes probiotics could benefit the oral, skin, and cognitive health. © Getty Images
By modulating the gut microbiome, South Korean firm Bifido INC believes probiotics could benefit the oral, skin, and cognitive health. © Getty Images

Related tags: South korea, Probiotics

South Korean firm Bifido INC is conducting a series of human clinical trials at home and abroad as it seeks to make efficacy claims on product labels.

Bifido INC was founded in 1999 by Dr Geun Eog Ji, professor at the Food Science and Nutrition faculty in Seoul National University.

Specialising in both probiotics and pharmabiotics, the company was selected as the National Research Lab for Probiotics in 2003. It is also listed on the Korea Exchange KOSDAQ.

Currently, it owns proprietary strains B. bifidum BGN4​ and B. longum BORI ​– both isolated from the gut of healthy Korean babies.

The former has shown to inhibit atopic dermatitis eczema​, while the latter has shown to inhibit rotavirus – a common cause of serious diarrhoea in infants and young children. 

The strains are incorporated in over 200 finished products, majority are ODM/OEM products, while the remaining are the company’s branded products sold as Zigunuk-Bifidus in South Korea.

Its in-house brand Zigunuk-Bifidus consists of probiotics for babies, the family, and women, with four SKUs for each category. Of which, the Zigunuk-Bifidus premium for the family is the bestseller.

About 10 per cent of its business is sale of the probiotics ingredients to markets outside of South Korea.

Aside from gut health, the company has expanded into probiotics for oral and skin health in the recent two to three years.

“Now is the microbiome era. Every company wants to make products related to the microbiome,”​ chief technical officer Prof Myeong Soo Park told NutraIngredients-Asia.

Its oral health probiotics – Zigunuk Bifidus Denti – is a tablet melt containing B. bifidum BGN4​ and B. longum BORI,L. acidophilus ​AD031, as well as kimchi extract powder to inhibit the growth of harmful bacteria.

Its skin health oral probiotics, on the other hand, contains B. bifidum ​BGN4, B. lactis ​AD011, and L. acidophilus ​AD031.

The company is planning to conduct double-blind placebo-controlled human clinical trials on the two formulations from this year onwards, to support its applications for making efficacy claims on the product labelling.

Study designs

The trial on the oral probiotics will find out if the product could inhibit halitosis and gingivitis – the inflammation of gums.

It will be a 12-week study involving 100 subjects, where the intervention group will need to take one tablet melt each day before going to bed. 

Whereas the trial on the skin health probiotics is an extension of a previous trial.

During the trial, mothers with history of childhood AD were randomised to take either a mixture of B. bifidum ​BGN4, B. lactis ​AD011, and L. acidophilus ​AD031, ​or placebo four to eight weeks before delivery and continue it until six months after delivery.

They also needed to breastfeed their infants exclusively during the first three months.

The study found that the incidence of infants developing eczema by the time they turned one year old was reduced significantly in the probiotic group.

About one in three from the probiotic group and two in three from the placebo group developed eczema.

The upcoming trial will be based on the same study designs; however, it will monitor the effects in the children until they turn at least two years old.

Prof Park added that the company planned to conduct clinical trials on another two probiotic formulations that could 1) improve cognitive health and 2) prevent urinary tract infections in women. 

“If the trial findings are promising, we will consider the addition of ingredients such as oligosaccharides, vitamins and minerals into the formulation,”​ he said. 

Overseas trials

Elsewhere in China, the company has already started hospital trials on the use of probiotics for autism and intestinal disease in children last year.

This is the first time that the company is running trials in China – also its largest ODM/OEM market.

“Our [product distributing] agent in China is looking for probiotic products with certain characteristics, which is why we are embarking on trials in China [to support the registration of health claims].” 

Comparing China and South Korea, he said that the latter has been characterised by intense market competition.

“In Korea, there are so many competitors, we need to improve our marketing power and market share,”​ Prof Park said.

In 2019, the probiotics production market in South Korea was worth KRW$277.5bn (US$234m), which was 45.2% higher than 2018.

Immune strains

On the other hand, the company is planning to screen for strains that have immunomodulating effects.

“In Korea, traditionally there is a lot of interest in probiotics for gut health but now there is also growing interest in probiotics for immune health.

“We believe the trend will go into the China market eventually,”​ Prof Park said. 

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