Abstract:
Abstract
Background: Extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) has emerged as an urgent
global health threat and is by the World Health Organization ranked as priority 1 among pathogens in need of new
treatment. Studies have shown high mortality in Tanzanian children with ESBL-E infections. Gut colonization of
ESBL-E, which is a potential risk factor of ESBL-E infections, is reported to be very high among children in Tanzania.
Probiotics may potentially reduce gut colonization of multidrug-resistant bacteria. However, there is limited data on
whether probiotics may reduce ESBL-E carriage in infants. The ProRIDE Trial aims to evaluate whether the use of
probiotics can reduce morbidity and mortality among infants in Haydom, Tanzania, and whether this effect is
associated with a reduction in ESBL-E colonization and/or infections.
Methods/design: This large randomized double-blinded placebo-controlled trial aims to recruit 2000 newborn
infants at Haydom Lutheran Hospital and the surrounding area in the period of November 2020 to November
2021. Participants will be enrolled from days 0 to 3 after birth and randomized to receive probiotics or
placebo for 4 weeks. Participants will be followed-up for 6 months, during which three visits will be made to
collect clinical and demographic information, as well as rectal swabs and fecal samples which will be
subjected to laboratory analysis. The primary composite outcome is the prevalence of death and/or
hospitalization at 6 months of age Discussion: As the use of probiotics may give a more favorable gut composition, and thereby improve
health and reduce morbidity and mortality, the results may have implications for future therapy guidelines in
Africa and internationally.
Trial registration: ClinicalTrials.gov NCT04172012. Registered on November 21, 2019
Keywords: Newborn, Infants, Probiotics, Gut colonization, Extended-spectrum beta-lactamase, ESBL,
Enterobacteriaceae, Infant mortality, Hospitalization, Microbiota, Resistome, Randomized controlled trial
