Table 3.

SPIRIT schedule for enrolment, interventions, and assessments

	Enrolment	Allocation	Intervention			Close-out
Timepoint	0	0	30th	60th	90th	120th
Enrolment
Eligibility screen	X
Written informed consent	X
Collect demographics and baseline clinical data	X
Collect a biological sample	O				O
Allocation		X
Interventions
Intervention group
Control group
Assessments
LPSI	X		X	X	X
Reported adverse events			X	X	X
Demographics and baseline clinical data	X
Microbial profile						O

O, 50% of the participants were randomly chosen to collect saliva, feces, and skin samples.