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 |
| Sex |
7 (77.8) |
9 (81.8) |
19 (95.0) |
| 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 constipation |
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) |
4.2 ± 2.5 | 4.0 ± 1.3 | 4.1 ± 2.1 |
| Daily abdominal discomfort severity (1-10) |
3.8 ± 2.2 | 3.6 ± 1.4 | 3.9 ± 1.8 |
| Daily bloating severity (1-10) |
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.
Data are presented as mean ± SD or n (%).