The Swansea 'Safety in Newborns' Study


It is now acknowledged that the acquisition of normal flora following birth is critical in the development of the neonatal immune system. In addition, sub-optimum development of microflora may result in deficiencies of immune development, such as a higher risk of developing allergic diseases like atopic eczema, asthma and rhinitis.

As such probiotics offer the opportunity to promote the correct development of the neonatal immune system and potentially lower the risk of allergy. Probiotics have long been considered safe to use for everyone including babies, but this has rarely been confirmed under rigorous study conditions.

The aim of the ‘Safety in Newborns’ Study

The study was aimed at providing documented evidence of the safety of the Lab4b probiotic in healthy newborn babies and their mothers.

How the ‘Safety in Newborns’ Study was set up

  • 454 mother /baby pairs took part in the trial.
  • Half of the mothers took the 10 billion of the Lab4b probiotic per day during the last trimester and then gave the same probiotic to their newborn babies every day for 6 months following birth.
  • Half the mothers and babies took the dummy preparation.
  • All adverse health events were recorded in both the mother and baby to determine whether there was any differences between the probiotic and placebo (dummy capsule) group.

The results

No differences were found in total adverse events either in the babies or the mothers between the Lab4b probiotic group and the placebo group.