Table 4.

Association between bsh copy number on Day 0 and nausea and vomit in ITT population, based on generalized linear mixed-effects models. Fixed effects included probiotics, gestational age, bsh at Day 0, and its interaction between probiotics. Interaction between bsh and probiotics was removed from the final model due to no significance. ** indicates p < 0.01, * indicates p < 0.05.

	Biomarker = Log-Transformed Bsh Copy Number
Symptoms	Number of Participants (Observation Days)	Incidence Rate Ratio a (95% CI)	p-Value	Odds Ratio b (95% CI)	p-Value
Daily nausea score (1–5)	25 (416)			0.71 (0.34, 1.48)	0.36
Daily vomit score (1–5) b	10 (166)			0.20 (0.06, 0.72) *	0.02
Daily nausea times	25 (415)	0.94 (0.75, 1.18)	0.60
Daily vomiting times c	10 (166)	0.50 (0.31, 0.81) **	0.005

^a Incidence rate ratio (IRR) of a 1-unit increase in log-transformed bsh on Day 0, based on Poisson mixed-effects model for count outcomes. IRR < 1 means that patients with high bsh copy numbers on Day 0 are associated with a low outcome during the entire study (after adjusting for probiotic effect). ^b Odds ratios on increasing to the next higher level of symptoms when there is a 1-unit increase in log-transformed bsh on Day 0, based on an ordinal logistic mixed-effects model for ordinal symptoms. The symptoms are on a 5-point Likert scale, with 1 = lowest and 5 = highest. OR < 1 means that patients with a high bsh level on Day 0 are associated with low symptom scores during the entire study (after adjusting for probiotic effect). ^c Participants without vomiting at enrollment were excluded.