Journal of Neurogastroenterology and Motility : eISSN 2093-0887 / pISSN 2093-0879

Table. 1.

Demographic and Baseline Characteristics, Intention to Treat Population

Patient characteristics Treatment assignment

Placebo (n = 9) Carboxymethylcellulose (n = 11) CSP01 (n = 20)
Age (yr) 51.9 ± 12.7 41.5 ± 17.7 44.9 ± 18.1
SexFemaleMale 7 (77.8)2 (22.2) 9 (81.8)2 (18.2) 19 (95.0)1 (5.0)
Race
White 8 (88.9) 8 (72.7) 16 (80.0)
Non-white 1 (11.1) 3 (27.3) 4 (20.0)
Body mass index (kg/m2) 24.2 ± 4.6 25.4 ± 3.0 25.9 ± 4.8
Rome IV diagnosis
CIC 4 (44.4) 9 (81.8) 14 (70.0)
IBS-C 5 (55.6) 2 (18.2) 6 (30.0)
Colonic transit time (min) 3088 ± 2083 3524 ± 2792 3288 ± 1838
Slow-transit constipationa 3.0 ± 33.3 5.0 ± 45.5 7.0 ± 35.0
Stool frequency per day 0.8 ± 0.4 0.7 ± 0.4 0.8 ± 0.3
Stool consistency per BM (BSFS 1-7) 2.6 ± 1.1 3.1 ± 1.1 3.0 ± 1.2
Ease of passage scale per BM (1-7) 3.9 ± 0.7 3.5 ± 0.5 3.6 ± 0.6
Number of CSBMs per day 0.2 ± 0.3 0.2 ± 0.2 0.2 ± 0.2
Daily constipation severity (1-10)b 4.2 ± 2.5 4.0 ± 1.3 4.1 ± 2.1
Daily abdominal discomfort severity (1-10)b 3.8 ± 2.2 3.6 ± 1.4 3.9 ± 1.8
Daily bloating severity (1-10)b 4.7 ± 2.5 4.4 ± 1.4 4.4 ± 2.2

aSlow-transit constipation defined as colonic transit time ≥ 59 hours at baseline.

bHigher values indicate increased severity of symptoms.

CIC, chronic idiopathic constipation; IBS-C, irritable bowel syndrome with constipation; BM, bowel movement; BSFS, Bristol Stool Form Scale; CSBM, complete spontaneous bowel movement.

P-values were calculated with the use of analysis of variance for continuous data and chi square tests for categorical data.

Data are presented as mean ± SD or n (%).

J Neurogastroenterol Motil 2020;26:496~504 https://doi.org/10.5056/jnm20001
© J Neurogastroenterol Motil