Probi has performed one of the first tolerance studies with both a L. plantarum strain and a L. rhamnosus strain in a newborn population. L. plantarum has not been studied in an infant population this young before.
The youngest baby in the study was recruited already at 4 days of age and started consuming probiotics at 11 days of age.
The primary objective of this parallel, double blind, randomized, placebo-controlled pilot study was to evaluate the tolerance of L. plantarum HEAL9 (HEAL9TM) and L. rhamnosus 271 in healthy infants. The study has now been published.
Infants are born with a low microbial content of the gastrointestinal tract which might be susceptible to distress. Over time, they develop the microbiota that will help them build a barrier in their GI tract, gain a stronger immune system, and prevent infections. A baby acquires good bacteria from breast milk and later food, but probiotics may help add good bacteria to a newborn’s gastrointestinal system more quickly.
Newborns are a vulnerable group, and it is of utmost importance that any supplements administered are safe. It is also important to bear in mind that probiotics have strain-specific effects, and safety aspects of each new strain must be assessed. Strains of L. rhamnosus have for a long time been used as probiotics for infants and children in a wide range of different probiotic products, marketed in many countries. However, L. plantarum is a species that seldom has been analyzed in infants.
Titti Niskanen, Director R&D & Clinical Operations at Probi explains: “Even though L. plantarum is a species that seldom has been analyzed in newborns, it could be detected in 25% of the subjects before administration (mean age 41 days). The L. plantarum and L. rhamnosus strains establish well in the intestine of the newborns and are safe. Intake of the study product was safe and did not result in any adverse effects on growth and infant behavior.”
“Furthermore, the study suggests that the two strains might have immune-supporting effects, as none of the newborns in the probiotic group experienced an upper respiratory tract infection (URTI) while 25% in the placebo group suffered from an infection during the study.” Niskanen adds.
Tom Rönnlund, CEO at Probi says: “Safety data are necessary for marketing and sales of probiotic strains, in particular targeting infants or young children, but also for products targeting adults and sensitive populations.” “This study adds to our knowledge of probiotics in newborns and children, and we will evaluate further investigations in the health benefits in infants,” Tom Rönnlund ends.