New research suggests bacterial probiotics may be associated with dangerous infections in newborn babies. Between February 2012 and August 2013, an outbreak of vancomycin resistant Enterococcus (VRE) in infants in a hospital NICU. Infants sickened in the outbreak were part of a clinical trial using a bacterial probiotic. The bacteria used in the probiotic product were Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium lactis, fructooligosaccharide, galactooligosaccharide, colostrums, and lactoferrin.

The study, published in the The Journal of Maternal-Fetal & Neonatal Medicine (citation at the end of this article), concluded:

“The results of our study demonstrate for the first time that bacterial probiotic administration to
newborn infants may be a risk factor for VRE colonisation”

The Probiotics Clinical Trial

In the NICU,  210 infants were chosen to participate in a clinical trial of a probiotic product that doctors hoped with prevent nectrotizing enterocolitis (NEC), a dangerous disease that kills bowel tissue and can be fatal. Twice a day in breast milk or formula, the infants were given the probiotic product containing 820 million Lactobacillus rhamnosus, 410 million L. plantarum, 410 million L. casei, 410 million Bifidobacterium lactis, fructooligosaccharide, galactooligosaccharide, colostrums, and lactoferrin.

A nurse who was not involved in the care of the infants prepared the probiotic supplements. This lessened the risk of infection spreading from one child to another.

The VRE Outbreak

Several infants participating in the probiotic trial were sickened by vancomycin resistant Enterococcus (VRE) that had colonized in their intestines. VRE are antibiotic resistant (vancomycin) bacteria (Enterococcus). One of the primary risk factors for VRE colonization in newborns is “long term antibiotic therapy, especially with vancomycin and cephalosporins,” according to the article. Vancomycin resistance is a gene mutation.

Enterococci bacteria can exchange vancomycin resistant genes with Enterococcus species or other microorganisms, including Lactobacillus species, according to the article. The authors of the study suggest that Lactobacillus rhamnosus, an ingredient in the probiotic given to the newborns, played a role in transferring antibiotic resistance to the Enterococcus. One supporting fact for this theory is that the outbreak ended when the probiotic clinical trial ended.

What Should Parents Do?

Armed with this information (the citation for the article is below), parents should discuss the risk of serious injury from infection with their doctors before giving their babies bacterial probiotics containing Lactobacillus rhamnosus.  Parents whose children have suffered from a severe infection after ingesting probiotics can contact our attorneys who represent children and their families throughout the United States and have substantial experience with infection cases. You can call 1-888-377-8900 to find out if a probiotic product was the cause, at least in part, of your child’s infection.

See also: Recall of ABC Dophilus Probiotic Due to Baby Death.


Topcuoglu, Sevilay, et al. A new risk factor for neonatal vancomycin resistant Enterococcus
colonisation: bacterial probiotics. The Journal of Maternal-Fetal & Neonatal Medicine. 2014 Sep 19:1-4.