Table 3.

Parameters assessed with participants' diaries in the ITT and BMF≤3/week populations. Results are expressed weekly: Day 0 = Day -7 to Day -1, Day 28 = Day 21 to Day 27.

	ITT				BMF≤3/week
	Total	High dose	Low dose	Placebo	Total	High dose	Low dose	Placebo
Bowel Movement Frequency (BMF)
Day 0	4.59 ± 2.20	4.89 ± 2.42	4.76 ± 2.43	4.13 ± 1.60	2.75 ± 0.83	2.68 ± 0.82	2.78 ± 0.85	2.78 ± 0.85
Day 28	5.16 ± 2.18	5.56 ± 2.45	5.39 ± 2.20	4.54 ± 1.70	4.20 ± 2.11	4.68 ± 1.89	4.43 ± 2.61	3.57 ± 1.59
Δ	0.57 ± 1.53	0.67 ± 1.69	0.62 ± 1.67	0.41 ± 1.18	1.45 ± 2.19	2.00 ± 1.97	1.65 ± 2.72	0.78 ± 1.62
Bristol Stool Scale (BSS)
Day 0	3.30 ± 1.09	3.34 ± 1.12	3.27 ± 1.11	3.30 ± 1.06	3.36 ± 1.30	3.88 ± 1.55	2.87 ± 1.11	3.42 ± 1.09
Day 28	3.51 ± 1.08	3.4 6± 1.11	3.52 ± 1.19	3.56 ± 0.96	3.67 ± 1.27	3.80 ± 1.31	3.48 ± 1.23	3.74 ± 1.32
Δ	0.21 ± 0.87	0.12 ± 0.89	0.26 ± 0.82	0.25 ± 0.91	0.31 ± 1.39	-0.08 ± 1.65	0.61 ± 1.11	0.32 ± 1.40
Degree of Straining
Day 0	2.43 ± 0.73	2.33 ± 0.73	2.41 ± 0.74	2.54 ± 0.72	2.55 ± 0.91	2.22 ± 0.87	2.61 ± 0.92	2.78 ± 0.89
Day 28	2.13 ± 0.68	2.11 ± 0.72	2.08 ± 0.70	2.20 ± 0.61	2.10 ± 0.77	1.70 ± 0.64*	2.18 ± 0.79	2.35 ± 0.77
Δ	-0.29 ± 0.60	-0.21 ± 0.64	-0.31 ± 0.57	-0.33 ± 0.59	-0.46 ± 0.95	-0.52 ± 0.72	-0.43 ± 1.06	-0.44 ± 1.03
Complete Bowel Emptying
Day 0	0.44 ± 0.31	0.47 ± 0.31	0.39 ± 0.30	0.47 ± 0.31	0.51 ± 0.39	0.52 ± 0.43	0.56 ± 0.41	0.44 ± 0.36
Day 28	0.54 ± 0.33	0.58 ± 0.34	0.49 ± 0.33	0.55 ± 0.31	0.62 ± 0.36	0.68 ± 0.37	0.59 ± 0.35	0.61 ± 0.38
Δ	0.09 ± 0.25	0.11 ± 0.26	0.09 ± 0.24	0.08 ± 0.25	0.12 ± 0.42	0.16 ± 0.40	0.03 ± 0.42	0.18 ± 0.44
Abdominal Pain
Day 0	1.70 ± 0.63	1.66 ± 0.56	1.76 ± 0.71	1.70 ± 0.63	1.56 ± 0.66	1.45 ± 0.52	1.65 ± 0.88	1.57 ± 0.51
Day 28	1.58 ± 0.62	1.57 ± 0.62	1.63 ± 0.71	1.55 ± 0.52	1.46 ± 0.51	1.32 ± 0.49	1.48 ± 0.54	1.55 ± 0.49
Δ	-0.12 ± 0.46	-0.09 ± 0.49	-0.13 ± 0.50	-0.14 ± 0.37	-0.11 ± 0.59	-0.13 ± 0.56	-0.17 ± 0.71	-0.03 ± 0.49
Bloating
Day 0	1.81 ± 0.69	1.81 ± 0.69	1.81 ± 0.70	1.80 ± 0.69	1.75 ± 0.78	1.62 ± 0.61	1.90 ± 0.99	1.70 ± 0.67
Day 28	1.67 ± 0.68	1.68 ± 0.70	1.68 ± 0.76	1.65 ± 0.58	1.54 ± 0.61	1.38 ± 0.45	1.56 ± 0.77	1.64 ± 0.55
Δ	-0.14 ± 0.48	-0.12 ± 0.49	-0.13 ± 0.54	-0.15 ± 0.39	-0.21 ± 0.62	-0.25 ± 0.66	-0.34 ± 0.67	-0.05 ± 0.52

BMF≤3/week, participants from the ITT population who had fewer than or equal to 3 bowel movements per week during the entire 14-day run-in period; high-dose group, 1 × 10¹⁰ CFU of HN019/day; ITT, intention-to-treat population—all participants randomized at the second visit who consumed at least 2 dose of the study product; low-dose group 1 × 10⁹ CFU of HN019/day; Δ, change from Day 0 to Day 28. Values are mean ± standard deviation. *P value < 0.05 compared with the placebo group.