Table 2.

Parameters measured on Day 0 (baseline) and Day 28 (end of study) in the ITT and BMF≤3/week populations.

	ITT				BMF≤3/week
	Total	High dose	Low dose	Placebo	Total	High dose	Low dose	Placebo
Colonic Transit Time (CTT)
Day 0	63.97 ± 35.07	67.55 ± 35.68	60.53 ± 35.40	63.84 ± 34.21	65.38 ± 34.20	65.00 ± 42.47	65.91 ± 34.94	65.17 ± 26.55
Day 28	62.34 ± 34.17	66.70 ± 32.07	62.54 ± 36.68	57.88 ± 33.51	65.46 ± 31.89	68.37 ± 27.12	62.22 ± 36.64	66.30 ± 31.56
Δ	-1.78 ± 32.38	-1.09 ± 34.07	1.82 ± 33.49	-5.96 ± 29.40	0.08 ± 35.54	3.37 ± 46.94	-3.70 ± 31.54	1.13 ± 29.16
Patient Assessment of Constipation Symptoms (PAC-SYM)
Abdominal Symptoms Score
Day 0	0.98 ± 0.69	0.98 ± 0.72	1.02 ± 0.66	0.94 ± 0.69	0.82 ± 0.64	0.81 ± 0.71	0.82 ± 0.67	0.85 ± 0.57
Day 28	0.87 ± 0.61	0.86 ± 0.61	0.85 ± 0.59	0.88 ± 0 .64	0.76 ± 0.50	0.74 ± 0.50	0.74 ± 0.52	0.78 ± 0.49
Δ	-0.10 ± 0.54	-0.10 ± 0.59	-0.15 ± 0.51	-0.06 ± 0.53	-0.07 ± 0.54	-0.07 ± 0.58	-0.08 ± 0.54	-0.07 ± 0.54
Rectal Symptoms Score
Day 0	0.55 ± 0.68	0.51 ± 0.64	0.49 ± 0.63	0.65 ± 0.75	0.63 ± 0.73	0.48 ± 0.63	0.67 ± 0.80	0.71 ± 0.75
Day 28	0.44 ± 0.58	0.47 ± 0.58	0.45 ± 0.59	0.40 ± 0.58	0.36 ± 0.47	0.39 ± 0.56	0.40 ± 0.49	0.30 ± 0.39
Δ	-0.11 ± 0.63	-0.04 ± 0.58*	-0.04 ± 0.54	-0.25 ± 0.74	-0.27 ± 0.59	-0.09 ± 0.36	-0.28 ± 0.61	-0.42 ± 0.70
Stool Symptoms Score
Day 0	1.48 ± 0.85	1.42 ± 0.88	1.54 ± 0.84	1.48 ± 0.84	1.39 ± 0.84	1.08 ± 0.71	1.66 ± 0.91	1.38 ± 0.81
Day 28	1.21 ± 0.85	1.22 ± 0.83	1.28 ± 0.91	1.11 ± 0.81	0.97 ± 0.72	0.99 ± 0.67	1.10 ± 0.75	0.83 ± 0.73
Δ	-0.25 ± 0.66	-0.16 ± 0.59	-0.24 ± 0.72	-0.37 ± 0.66	-0.42 ± 0.70	-0.09 ± 0.50	-0.57 ± 0.83	-0.56 ± 0.62
Overall Score
Day 0	1.08 ± 0.58	1.04 ± 0.61	1.10 ± 0.58	1.09 ± 0.57	1.01 ± 0.55	0.83 ± 0.46	1.13 ± 0.62	1.04 ± 0.53
Day 28	0.90 ± 0.58	0.91 ± 0.57	0.93 ± 0.60	0.86 ± 0.57	0.74 ± 0.43	0.75 ± 0.42	0.80 ± 0.46	0.68 ± 0.43
Δ	-0.17 ± 0.46	-0.11 ± 0.44	-0.16 ± 0.45	-0.23 ± 0.48	-0.27 ± 0.45	-0.08 ±0.32	-0.33 ± 0.54	-0.36 ± 0.41
Patient Assessment of Constipation Quality of Life (PAC-QoL)
Physical Discomfort Score
Day 0	1.17 ± 0.84	1.16 ± 0.84	1.18 ± 0.88	1.18 ± 0.80	1.11 ± 0.72	1.11 ± 0.62	1.12 ± 0.82	1.10 ± 0.72
Day 28	0.91 ± 0.83	0.97 ± 0.82	0.89 ± 0.86	0.87 ± 0.81	0.80 ± 0.67	0.84 ± 0.54	0.73 ± 0.65	0.84 ± 0.80
Δ	-0.24 ± 0.70	-0.17 ± 0.74	-0.26 ± 0.65	-0.31 ± 0.69	-0.31 ± 0.60	-0.26 ± 0.46	-0.39 ± 0.61	-0.26 ± 0.70
Psychosocial Discomfort Score
Day 0	0.59 ± 0.60	0.52 ± 0.53	0.60 ± 0.59	0.65 ± 0.67	0.53 ± 0.54	0.63 ± 0.59	0.54 ± 0.61	0.44 ± 0.43
Day 28	0.45 ± 0.54	0.40 ± 0.43	0.47 ± 0.60	0.49 ± 0.59	0.30 ± 0.33	0.34 ± 0.28	0.35 ± 0.46	0.22 ± 0.21
Δ	-0.13 ± 0.47	-0.10 ± 0.41	-0.12 ± 0.50	-0.16 ± 0.51	-0.23 ± 0.47	-0.29 ± 0.49	-0.19 ± 0.54	-0.22 ± 0.37
Worries and Concerns Score
Day 0	0.93 ± 0.73	0.88 ± 0.70	0.91 ± 0.75	1.00 ± 0.73	0.89 ± 0.63	1.03 ± 0.57	0.87 ± 0.74	0.80 ± 0.63
Day 28	0.71 ± 0.64	0.67 ± 0.59	0.67 ± 0.62	0.79 ± 0.71	0.64 ± 0.54	0.68 ± 0.54	0.59 ± 0.52	0.66 ± 0.58
Δ	-0.20 ± 0.48	-0.19 ± 0.49	-0.21 ± 0.52	-0.20 ± 0.43	-0.25 ± 0.42	-0.35 ± 0.48	-0.29 ± 0.42	-0.14 ± 0.36
Satisfaction Score
Day 0	2.41 ± 0.77	2.32 ± 0.77	2.35 ± 0.72	2.56 ± 0.81	2.71 ± 0.71	2.78 ± 0.60	2.50 ± 0.72	2.87 ± 0.75
Day 28	2.21 ± 0.79	2.19 ± 0.75	2.22 ± 0.85	2.22 ± 0.79	2.34 ± 0.79	2.23 ± 0.81	2.25 ± 0.74	2.51 ± 0.82
Δ	-0.20 ± 0.81	-0.13 ± 0.78	-0.13 ± 0.83	-0.33 ± 0.81	-0.38 ± 0.84	-0.55 ± 0.73	-0.25 ± 0.89	-0.36 ± 0.90
Overall Score
Day 0	1.13 ± 0.56	1.07 ± 0.54	1.12 ± 0.57	1.20 ± 0.57	1.15 ± 0.47	1.24 ± 0.42	1.10 ± 0.55	1.11 ± 0.44
Day 28	0.93 ± 0.52	0.91 ± 0.48	0.92 ± 0.54	0.97 ± 0.55	0.87 ± 0.41	0.88 ± 0.41	0.84 ± 0.37	0.89 ± 0.45
Δ	-0.19 ± 0.41	-0.15 ± 0.40	-0.17 ± 0.42	-0.23 ± 0.39	-0.28 ± 0.36	-0.36 ± 0.35	-0.27 ± 0.33	-0.22 ± 0.39
Bowel Function Index (BFI)
Day 0	56.57 ± 25.73	52.69 ± 24.74	58.54 ± 27.92	58.49 ± 24.27	62.90 ± 25.03	53.16 ± 18.57	66.23 ± 29.69	67.62 ± 23.29
Day 28	48.17 ± 25.97	47.77 ± 27.36	47.74 ± 25.21	49.00 ± 25.64	47.25 ± 22.58	47.49 ± 22.84	46.01 ± 18.18	48.28 ± 26.90
Δ	-8.03 ± 24.35	-4.45 ± 23.03	-10.12 ± 25.83	-9.50 ± 24.06	-15.66 ± 24.60	-5.67 ± 22.86	-20.22 ± 24.29	-19.35 ± 24.92

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 1 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.