Table 1.
Baseline characteristics of patients.
| IBD98-M 0.8 g/day (n = 17) n (%) | IBD98-M 1.2 g/day (N = 16) n (%) | Placebo (N = 18) n (%) | Total (N = 51) n (%) | |
|---|---|---|---|---|
| Age (years), Mean ± SD | 36.6 ± 10.68 | 43.1 ± 12.23 | 45.8 ± 12.21 | 41.9 ± 12.14 |
| Males | 12 (70.6) | 7 (43.8) | 9 (50.0) | 28 (54.9) |
| Current smokers | 0 | 1 (6.3) | 0 | 1 (2.0) |
| BMI at Screening (kg/m2), Mean ± SD | 24.08 ± 3.104 | 25.22 ± 3.771 | 24.38 ± 4.016 | 24.54 ± 3.614 |
| Baseline UCDAI | ||||
| ≤5 | 7 (43.8) | 7 (43.8) | 9 (50.0) | 23 (45.1%) |
| 6–8 | 5 (31.3) | 4 (25.0) | 9 (50.0) | 18 (35.2%) |
| 9–10 | 4 (25.0) | 5 (31.3) | 0 (0.0) | 9 (17.7%) |
| Mean endoscopic score | 2.08 | 1.79 | 1.86 | 1.90 |
| Concomitant medications | ||||
| Agents acting on the renin-angiotensin system | 1 (5.9) | 0 | 3 (16.7) | 4 (7.8) |
| Ace inhibitors | 1 (5.9) | 0 | 2 (11.1) | 3 (5.9) |
| Ramipril | 0 | 0 | 2 (11.1) | 2 (3.9) |
| Analgesics | 5 (29.4) | 5 (31.3) | 5 (27.8) | 15 (29.4) |
| Anilides | 5 (29.4 | 5 (31.3) | 5 (27.8) | 15 (29.4) |
| Paracetamol | 5 (29.4) | 5 (31.3) | 5 (27.8) | 15 (29.4) |
| Antianemic preparations | 1 (5.9) | 1 (6.3) | 0 | 2 (3.9) |
| Iron, parenteral preparations | 1 (5.9) | 1 (6.3) | 0 | 2 (3.9) |
| Ferric carboxymaltose | 1 (5.9) | 1 (6.3) | 0 | 2 (3.9) |
| Antibacterials for systemic use | 2 (11.8) | 1 (6.3) | 2 (11.1) | 5 (9.8) |
| Penicillins, incl. Beta-lactamase inhibitors | 1 (5.9) | 0 | 1 (5.6) | 2 (3.9) |
| Amoxicillin + clavulanic acid | 1 (5.9) | 0 | 1 (5.6) | 2 (3.9) |
| Antidiarrheals, intestinal anti-inflammatory/anti-infectious agents | 6 (35.3) | 7 (43.8) | 7 (38.9) | 20 (39.2) |
| Aminosalicylic acid and similar agents | 4 (23.5) | 7 (43.8) | 7 (38.9) | 18 (35.3) |
| Mesalazine | 4 (23.5) | 7 (43.8) | 7 (38.9) | 18 (35.3) |
| Antidiarrheal microorganisms | 2 (11.8) | 0 | 2 (11.1) | 4 (7.8) |
| Corticosteroids acting locally | 2 (11.8) | 1 (6.3) | 1 (5.6) | 4 (7.8) |
| Prednisone | 2 (11.8) | 0 | 1 (5.6) | 3 (5.9) |
| Anti-inflammatory and anti-rheumatic products | 2 (11.8) | 2 (12.5) | 2 (11.1) | 6 (11.8) |
| Propionic acid derivatives | 2 (11.8) | 1 (6.3) | 2 (11.1) | 5 (9.8) |
| Ketoprofen | 2 (11.8) | 1 (6.3) | 0 | 3 (5.9) |
| Ibuprofen | 0 | 0 | 2 (11.1) | 2 (3.9) |
| Cough and cold preparations | 1 (5.9) | 0 | 2 (11.1) | 3 (5.9) |
| Other cough suppressants | 1 (5.9) | 0 | 1 (5.6) | 2 (3.9) |
| Drugs for acid related disorders | 1 (5.9) | 1 (6.3) | 2 (11.1) | 4 (7.8) |
| Proton pump inhibitors | 1 (5.9) | 1 (6.3) | 1 (5.6) | 3 (5.9) |
| Lansoprazole | 1 (5.9) | 0 | 1 (5.6) | 2 (3.9) |
| Drugs for constipation | 4 (23.5) | 6 (37.5) | 3 (16.7) | 13 (25.5) |
| Enemas | 4 (23.5) | 6 (37.5) | 2 (11.1) | 12 (23.5) |
| Fleet | 1 (5.9) | 4 (25.0) | 1 (5.6) | 6 (11.8) |
| Sodium phosphate | 2 (11.8) | 1 (0.3) | 1 (5.6) | 4 (7.8) |
| Mineral supplements | 1 (5.9) | 1 (6.3) | 1 (5.6) | 3 (5.9) |
| Calcium, combinations with vitamin d and/or other drugs | 1 (5.9) | 1 (6.3) | 1 (5.6) | 3 (5.9) |
| Calcium w/colecalciferol | 1 (5.9) | 0 | 1 (5.6) | 2 (3.9) |
| Psycholeptics | 2 (11.8) | 1 (6.3) | 1 (5.6) | 4 (7.8) |
| Benzodiazepine derivatives | 1 (5.9) | 0 | 1 (5.6) | 2 (3.9) |
| Benzodiazepine derivatives | 1 (5.9) | 1 (6.3) | 0 | 2 (3.9) |
Abbreviation: IBD: inflammatory bowel disease; SD = standard deviation; UCDAI = Ulcerative Colitis Disease Activity Index. Percentages were calculated based on the number of patients in the safety population in each treatment group.