Patient characteristics in the VSL#3 and placebo groups
| VSL#3 (n = 20) | Placebo (n = 16) | p Value | |
|---|---|---|---|
| UC, ulcerative colitis; PDAI, pouchitis disease activity index; IBDQ, inflammatory bowel disease questionnaire. | |||
| Sex (M/F) | 12/8 | 8/8 | 0.74 |
| Age (y) | 36 (22–64) | 36 (27–53) | 0.97 |
| Age at UC onset (y) | 24 (12–49) | 22 (13–37) | 0.44 |
| Age at pouch surgery (y) | 33 (14–60) | 31 (17–51) | 0.76 |
| Time between ileostomy closure and first pouchitis onset (months) | 9.5 (0.5–87) | 15 (0.5–72) | 0.69 |
| Time since the first pouchitis ever (months) | 26 (9–168) | 33 (10–118) | 0.34 |
| Clinical pattern of pouchitis (relapsing/chronic) | 14/6 | 12/4 | 1.0 |
| Extraintestinal manifestations (+/−) | 0/20 | 3/13 | 0.08 |
| PDAI score at randomisation | 3 (1–7) | 3 (1–4) | 0.70 |
| IBDQ score at randomisation | 189 (104–212) | 169 (154–215) | 0.38 |