The first consumer product containing a probiotic strain derived from human milk by Puleva Biotech has launched in Spain, and the company hopes it may find a home in other foods for infants and adults.
The fermented dairy product is marketed under the Max Defensas brand by Ebro Puleva, Puleva Biotech's patent company, and aimed at boosting the immune systems of children aged between four and 12 years. It contains two probiotic strains: Lactobacillus gasseri from human milk. Lactobacillus coryneformis from goats cheese.
Puleva Biotec has been working in collaboration with the Universidad Complutense de Madrid since 1999 to identify beneficial strains from human milk. The result is the Hereditum line of probiotic bacteria, which consists of two Lactobacillus gasseri strains and one Lactobacillus fermentum.
The origin is unusual since most probiotic strains on the market were isolated from intestinal samples.
Researchers first identified probiotic bacteria in breast milk during the 1970s but it was not clear where the bacteria had come from. Then in the late 1980s Swedish firm BioGaia isolated strains of lactic acid bacteria from Peruvian mothers living in the highlands and screened them in their US laboratories for potential probiotic properties. This led to the development of its well-known Lactobacillus reuteri.
Managing vice-director Julio Boza told NutraIngredients.com that the timing of Puleva Biotech's research was fortuitous.
"We have taken advantage of the fact that we came to the probiotic area later," he said. "We have been able to select the bacteria using the criteria that others are using."
The strains were selected from around 200 samples based on between 40 and 50 selection criteria. This has meant that the researchers have been able to be confident about the strains, and aspects such as their probiotic capabilities, fermentation profiles, safety and ability to inhibit the growth of pathogenic bacteria.
Once Puleva Biotech had selected strains, it developed a way to produce them through fermentation and scale up production. It has built a plant for this purpose; although it is currently only producing around 30,000 kg per year, Boza said that the plant is quite versatile and capacity can be stepped up as needed.
Although the first product containing a Hereditum strain has been introduced through Puleva Biotech's patent company, it is looking for outside partners who may wish to develop others.
In particular it believes the Hereditum strains could find a natural home in infant formulas, which Boza called "a hot topic right now".
It makes sense. After all, these bacteria are transferred to babies from their mothers to help shore up their immune systems.
This mother-baby transfer was investigated in a study published in the December 2003 issue of the Journal of Pediatrics (143: 754-8). Researchers from the Universidad Complutense de Madrid, backed by Puleva Biotech, confirmed that lactic acid bacteria in human milk "may have an endogenous origin and may not be the result of contamination from the surrounding breast skin".
The scientists studied bacteria isolated from the mammary areola, breast skin and vagina of eight mothers to compare it with the bacteria found in the gut of infants. They also tested samples of infant faeces and oral bacteria to assess whether breast milk contained the bacteria that colonised the infant's digestive tract.
The results suggest that bacteria in breast milk could be a natural probiotic for newborns. Moreover there is a strong possibility that the strains could be used in products aimed at adults.
"The singular origin of Hereditum makes them not only exceptional candidates for their use in infant nutrition, but also for several other applications in functional foods due to their excellent probiotic potential and technological versatility that ensures their maximum functionality and performance," says the company. "This is the case for dairy products, fermented or not, sugar rich matrices."
The Lactobacillus gasseri 19 CECT5714 and Lactobacillus coryniformis CECT5711 strains have been tested on adult humans in a randomized double-blind placebo controlled clinical trial, for their effect on several blood and fecal parameters, most of them related to the host intestinal function.
The 30 healthy adults received either a standard yoghurt or one in which the Lactobacillus delbreuckii subsp. Bulgaricus yogurt strain had been replaced by the two Puleva Biotech strains.
The concentration of fecal lactic acid bacteria was seen to significantly increase in the probiotic group, as were the production of 25 short chain fatty acids, the fecal moisture and the frequency and volume of the stools.
"The volunteers assigned to the probiotic group perceived a clear improvement in their intestinal habits. The study revealed that probiotics may exert a positive effect on healthy adults," wrote the researchers in the International Journal of Food Microbiology (published online in November 2005 ahead of print).
Boza dismissed the notion that adults may find the probiotic's origins off-putting.
"We take the position that it is found in the best and richest functional food we can have [ie human breast milk]," he said.
Frost & Sullivan has predicted that the probiotics market could increase as much as threefold this decade, to be worth $137.9 million (€118.5m) in Europe in 2010, and $394 million in the US.