Use of probiotics to reduce infections and death and prevent colonization with extended-spectrum beta-lactamase (ESBL)-producing bacteria among newborn infants in Tanzania (ProRIDE Trial): study protocol for a randomized controlled clinical trial

Table 1 Trial schedule procedures

Study period
	Enrolment	Allocation	Post-allocation
Timepoint	Screening	Baseline	7 days^*	6 weeks	6 months
Enrolment
Informed consent mother/caretaker	x
Eligibility screening newborn		x
Randomization newborn		x
Interventions
Probiotics		x	x
Placebo		x	x
Assessment
Rates of confirmed sepsis episodes				x	x
Rates of hospitalization				x	x
Growth by height and weight				x	x
Stool microbiota composition and resistome				x	x
Stool metabolome composition				x	x
Stool inflammatory markers					x
Genetic characteristics of ESBL-E and other MDR isolates				x	x
Prevalence ESBL-E carriage				x	x

Abbreviations: ESBL-E extended-spectrum beta-lactamase Enterobacteriaceae, MDR multidrug resistant
^*Observe for adherence and discuss issues with care takers

ISSN: 1745-6215