Table 1.
Baseline characteristics of the study group.
| Number of Patients | Study Group 72 |
Group A (Butyrate) 29 |
Group B (Placebo) 43 |
p | |
|---|---|---|---|---|---|
| Crohn’s disease (No. of patients) | 42 (58.3%) | 18 (62.1%) | 24 (55.8%) | 0.597 | |
| Mean age (years) | 13.3 (6–18) | 12.9 (6–17) | 13.5 (7–18) | 0.6 | |
| Gender (male) | 43 (59.7%) | 14 (48.3%) | 29 (67.1%) | 0.104 | |
| Median weight (kg) | 46 (SD 14.8) | 45 (SD 15.3) | 46.5 (SD 14.2) | 0.329 | |
| Median height (cm) | 158 (SD 19.4) | 158 (SD 20.9) | 159 (SD 17.9) | 0.620 | |
| Baseline activity index score (points) | Mean | 34.5 (12.5–85) | 34.7 (12.5–75) | 34.3 (12.5–85) | 0.554 |
| Median | 31.5 | 30 | 32.5 | - | |
| Calprotectin level (points) | Mean | 1111.1 (50–1800) | 1090 (50–1800) | 1122.2 (50–1800) | 0.599 |
| Median | 1100 | 900 | 1300 | - | |
| Amino-salicylates | 70 (97.2%) | 28 (96.5%) | 42 (97.7%) | 0.776 | |
| Steroids | 8 (11.0%) | 3 (10.3%) | 5 (11.6%) | 0.865 | |
| Thiopurines | 50 (69.5%) | 21 (72.4%) | 29 (67.4%) | 0.653 | |
| Anti-TNF | 10 (13.9%) | 4 (13.8%) | 6 (13.9%) | 0.985 | |
| Antibiotics | 18 (25.0%) | 8 (27.6%) | 10 (23.3%) | 0.677 | |
| Disesae extention (Paris criteria) *—colon involvement (No of patients) | |||||
| UC: E1/E2/E3/E4 | 5/7/3/15 | 3/3/1/8 | 2/4/2/7 | n.s. | |
| CD: L2/L3 | 5/34 | 3/14 | 2/20 | n.s. | |
* Colonic involvement according to Paris criteria: UC—E1: ulcerative proctitis, E2: left-sided UC (distal to splenic flexure), E3: extensive (hepatic flexure distally), E4: pancolitis (proximal to hepatic flexure); CD—L2: colonic, L3: ileocolonic. TNF—tumour necrosis factor, n.s.—not significant.