. Author manuscript; available in PMC: 2024 Feb 1.

Published in final edited form as: Lancet Microbe. 2023 Jan 13;4(2):e75–e83. doi: 10.1016/S2666-5247(22)00322-6

Table 2.

Trial results

	Stool CFU pre¹ [95% CI]	Stool CFU post² [95% CI]	% reduction (P value pre vs. post³)	P value OPTI-BIOME^® vs. placebo⁴	Nose CFU pre [95% CI]	Nose CFU post [95% CI]	% reduction (P value pre vs. post³)	P value OPTI-BIOME^® vs. placebo⁴
All participants OPTI-BIOME ^®	20213 [12026, 28401]	646 [261, 1031]	96·8 (<0·0001)	0·0001	1576 [1130, 2022]	564 [265, 863]	65·4 (<0·0001)	0·0002
All participants placebo	15350 [9729, 20971]	12532 [7547, 17571]	19·4 (0·12)		1306 [911, 1702]	1116 [756, 1476]	14·6 (0·084)
Participants only colonized in the intestine, OPTI-BIOME^®	18027 [8757, 27297]	659 [150, 1168]	96·3 (<0·0001)	0·0007	ND	ND	ND	ND
Participants only colonized in the intestine, placebo	14581 [8673, 20490]	12499 [6952, 18046]	14·3 (0·33)		ND	ND	ND
Participants only colonized in the nose, OPTI-BIOME^®	ND	ND	ND	ND	1508 [1059, 1956]	400 [176, 624]	73·5 (0·0005)	0·0035
Participants only colonized in the nose, placebo	ND	ND	ND		1288 [898, 1677]	1048 [673, 1423]	18·6 (0·13)
Participants colonized in nose and intestine, OPTI-BIOME^®	25680 [6591, 44769	612 [48, 1175]	97·6 (0·0005)	0·083	1650 [767, 2533]	742 [131, 1353]	55·0 (0·0005)	0·021
Participants colonized in nose and intestine, placebo	19194 [−2017, 40406]	12697 [−2537, 27931	34·0 (0·16)		1354 [71, 2638]	1291 [207, 2376]	4·7 (0·61)

^1,

pre, before intervention

^2,

post, after intervention

^3,

Wilcoxon matched-pairs signed-rank test

^4,

Mann-Whitney test of CFU differences in individuals at a given site