Table 3.

Analysis of the secondary outcomes in double-blind phase (ITT population)

Model	Placebo	Enterosgel	Treatment effect (95% CI)*	P value
Stool consistency (excluding weeks with <4 values)
Days ≥1 stool of BSFS 6/7 (week 1–8)†	3.16 (1.89)	2.46 (1.82)	−0.58 (−0.87 to −0.28)	0.0001
Days ≥1 stool of BSFS 6/7 (week 1–4)†	3.33 (1.85)	2.70 (1.85)	−0.50 (−0.79 to −0.21)	0.0007
Days ≥1 stool of BSFS 6/7 (week 5–8)†	2.92 (2.13)	2.08 (1.86)	−0.67 (−1.02 to −0.32)	0.0002
Abdominal pain (excluding weeks with <4 values)
Mean score (week 1–8)	4.02 (1.85)	3.59 (1.84)	−0.35 (−0.62 to −0.09)	0.0086
Mean score (week 5–8)	3.70 (1.99)	3.10 (1.96)	−0.50 (−0.83 to −0.18)	0.0026
Stool consistency (excluding weeks with <7 values)
Days ≥1 stool of BSFS 6/7 (week 1–8)†	3.14 (1.89)	2.47 (1.83)	−0.53 (−0.82 to −0.24)	0.0004
Days ≥1 stool of BSFS 6/7 (week 1–4)†	3.30 (1.87)	2.65 (1.83)	−0.50 (−0.80 to −0.21)	0.0009
Days ≥1 stool of BSFS 6/7 (week 5–8)†	2.94 (2.16)	1.96 (1.89)	−0.76 (−1.13 to −0.39)	<0.0001
Abdominal pain (excluding weeks with <7 values)
Mean score (week 1–8)	4.02 (1.85)	3.56 (1.83)	−0.36 (−0.63 to −0.10)	0.0079
Mean score (week 5–8)	3.64 (1.99)	2.93 (1.91)	−0.61 (−0.96 to −0.25)	0.0008
Stool frequency
Mean no daily stools (week 1–4)	2.96 (2.74–3.18)	2.67 (2.45–2.89)	−0.30 (−0.60 to 0.01)	0.0554
Mean no daily stools (week 5–8)	2.81 (2.59–3.03)	2.47 (2.25–2.69)	−0.35 (−0.66 to 0.04)	0.0251
Bloating
Mean bloating score (week 1–8)	3.14 (2.95–3.33)	2.73 (2.54–2.92)	−0.42 (−0.69 to 0.15)	0.0021
Mean bloating score (week 5–8)	3.06 (2.86–3.25)	2.50 (2.30–2.69)	−0.57 (−0.85 to 0.29)	<0.0001
Urgency
Mean urgency score (week 1–8)	3.08 (2.89–3.27)	2.51 (2.32–2.70)	−0.59 (−0.85 to 0.33)	<0.0001
Mean urgency score (week 5–8)	2.99 (2.79–3.19)	2.29 (2.09–2.48)	−0.72 (−0.99 to 0.44)	<0.0001
Adequate relief
Adequate relief (week 1–8)‡	0.22 (0.16–0.31)	0.56 (0.46–0.65)	4.44 (2.49 to 7.91)	<0.0001
Adequate relief (week 1–4)‡	0.16 (0.10–0.23)	0.45 (0.34–0.56)	4.40 (2.34 to 8.28)	<0.0001
Adequate relief (week 5–8)‡	0.30 (0.21–0.40)	0.69 (0.58–0.77)	5.21 (2.74 to 9.89)	<0.0001
Loperamide use
Loperamide use (week 1–8)§	1.46 (1.21–1.71)	0.97 (0.73–1.22)	−0.51 (−0.86 to −0.15)	0.0049
Loperamide use (week 5–8)§	1.55 (1.29–1.81)	0.97 (0.72–1.23)	−0.59 (−0.95 to −0.23)	0.0014

Data are reported as mean (SD or range) and treatment effect (95% CI).

*Adjusted for age, sex and the baseline measure of the outcome.

†Mean number of days per week with at least one stool of BSFS type 6 or 7 over.

‡Proportion of patients reporting adequate relief (95% CI).

§Mean number of days per week loperamide used.

BSFS, Bristol Stool Form Scale; ITT, intention-to-treat.