Table 1.
Baseline characteristics of the participants in the PP population
| Characteristics | PP total | Group |
p value | |
|---|---|---|---|---|
| placebo (n = 52) | L. gasseri OLL2716 (n = 54) | |||
| Age, years, mean ± SD† | 42.8±9.0 | 43.1±8.9 | 42.4±9.1 | 0.687 |
| Gender, n (%)§ | 1.000 | |||
| Female | 79 (74.5) | 39 (75.0) | 40 (74.0) | |
| Male | 27 (25.5) | 13 (25.0) | 14 (25.9) | |
| Height, cm, mean ± SD† | 162.5±8.2 | 162.4±8.8 | 162.6±7.6 | 0.913 |
| Weight, kg, mean ± SD† | 53.8±10.2 | 53.4±9.2 | 54.2±11.1 | 0.693 |
| BMI, kg/m2, mean ± SD† | 20.3±2.7 | 20.2±2.6 | 20.3±2.9 | 0.765 |
| FD subtype, n (%)§ | 0.933 | |||
| PDS alone | 68 (64.2) | 33 (63.5) | 35 (64.8) | |
| EPS-like alone | 13 (l2.3) | 7 (13.5) | 6 (11.1) | |
| Overlap with PDS and EPS-like | 25 (23.6) | 12 (23.1) | 13 (24.1) | |
| Individual FD symptoms scores, median (25–75 percentile)‡ | ||||
| Postprandial fullness | 3.00 (3.00–4.00) | 3.00 (3.00–4.00) | 4.00 (3.00–4.00) | 0.764 |
| Early satiety | 4.00 (3.00–4.00) | 4.00 (2.25–4.00) | 4.00 (3.00–4.00) | 0.968 |
| Epigastric pain | 2.00 (l.00–3.00) | 2.00 (1.25–3.75) | 2.00 (1.00–3.00) | 0.601 |
| Epigastric burning | 1.00 (1.00–2.00) | 1.00 (1.00–2.00) | 1.50 (1.00–2.00) | 0.900 |
| Reported gastrointestinal symptoms including minor symptoms, n (%)§ | ||||
| Postprandial fullness | 102 (96.2) | 50 (96.2) | 52 (96.3) | 1.000 |
| Early satiety | 100 (94.3) | 49 (94.2) | 51 (94.4) | 1.000 |
| Epigastric pain | 78 (73.6) | 39 (75.0) | 39 (72.2) | 0.827 |
| Epigastric burning | 51 (48.1) | 24 (46.2) | 27 (50.0) | 0.703 |
| Epigastric bloating | 92 (86.8) | 47 (90.4) | 45 (83.3) | 0.392 |
| Nausea | 33 (31.1) | 16 (30.8) | 17 (31.5) | 1.000 |
| Belching | 71 (67.0) | 36 (69.2) | 35 (64.8) | 0.683 |
| Heartburn | 55 (51.9) | 28 (53.8) | 27 (50.0) | 0.703 |
| Reflex feeling of gastric acid | 36 (34.0) | 19 (36.5) | 17 (31.5) | 0.683 |
| Abdominal bloating | 89 (84.0) | 45 (86.5) | 44 (81.5) | 0.599 |
| Occupation, n (%)§ | 0.661 | |||
| Company employee | 46 (43.4) | 22 (42.3) | 24 (44.4) | |
| Self-employed business | 6 (5.7) | 2 (3.8) | 4 (7.4) | |
| Part-time job | 19 (17.9) | 8 (15.4) | 11 (20.4) | |
| Student | 5 (4.7) | 3 (5.8) | 2 (3.7) | |
| Full-time homemaker | 29 (27.4) | 17 (32.7) | 12 (22.2) | |
| Unemployed | 1 (0.9) | 0 (0.0) | 1 (1.9) | |
PP, per-protocol; PDS, postprandial distress syndrome; EPS, epigastric pain syndrome.
Group comparison:
†
unpaired Student t test
‡
Wilcoxon rank sum test
§
Fisher's exact test.