Probiotic treatment of newborns to reduce colonization and disease caused by resistant bacteria (ProRIDE)

Infections with antibiotic-resistant bacteria is a major threat to healthcare worldwide, and sepsis, severe infection caused by such bacteria, is a major cause of neonatal death. It has been shown in Western countries that probiotics administered to premature infants improve their prognosis by preventing sepsis. In India a study of full-term infants demonstrated that symbiotics (similar but not identical to probiotics) reduced hospitalizations among children under one year of age after one week of treatment with symbiotics.

Our hypothesis is that probiotics reduce colonization with resistant bacteria in the gut of newborns and that this is the mechanism for reduced morbidity. 

The project is based on a double-blind, randomized controlled trial (ProRIDE (external link)) in which full-term newborns in Haydom, Tanzania, received either probiotic drops or placebo drops daily for one month. Probiotic drops contained probiotic mixture with different combination of bacteria, Lactobacillus acidophilus, Bifidobacterium infantis and Bifidobacterium breve.

The primary endpoint of the study is a combined outcome of death and/or hospitalizations within six months after birth. Secondary endpoints include load and content of resistant bacteria in the gut, the child’s growth, number of septic episodes, and gut microbiota composition at six weeks and six months of age. 
Hospitalizations during the inclusion period will form a substudy.

Our recent findings compared probiotics group to control group 6 months after treatment and showed no difference in the number of hospitalizations and deaths (3% in both groups). Neither there was any difference between groups in overall incidence of adverse events. However, fewer caregivers within the probiotics group reported that the newborns experienced gastrointestinal issues. This is a promising initial result and our research on this project continues.

Our research partner institutions on this project are Haydom Global Health Research Centre, Haydom Lutheran Hospital (external link), Haydom, Tanzania, Stavanger University Hospital (external link), Norway and Research Group for Child and Adolescent Health (external link), Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.