Table 2.
The clinical response rate for all (men and women) participants based on intention-to-treat (ITT) set
| Clinical response ratea, No. (%) | Placebo (n = 50) | Positive_control (n = 50) | BL-99_low (n = 50) | BL-99_high (n = 50) | poverall | p | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Positive_control vs. Placebo | BL-99_low vs. Placebo | BL-99_high vs. Placebo | BL-99_low vs. Positive_control | BL-99_high vs. Positive_control | BL-99_high vs. BL-99_low | |||||||
| 4-week treatment | FD scoreb | 29 (58.0) | 28 (56.0) | 28 (56.0) | 38 (76.0) | 0.113 | – | – | – | – | – | – |
| PDS scorec | 31 (62.0) | 32 (64.0) | 37 (74.0) | 43 (86.0) | 0.031 | 0.440 | 0.200 | 0.008 | 0.281 | 0.014 | 0.139 | |
| EPS scored | 24 (48.0) | 23 (46.0) | 25 (50.0) | 35 (70.0) | 0.059 | – | – | – | – | – | – | |
| 8-week treatment | FD score | 29 (58.0) | 35 (70.0) | 37 (74.0) | 45 (90.0) | 0.004 | 0.213 | 0.094 | 0.001 | 0.656 | 0.017 | 0.044 |
| PDS score | 34 (68.0) | 39 (78.0) | 40 80.0) | 44 (88.0) | 0.111 | – | – | – | – | – | – | |
| EPS score | 24 (48.0) | 27 (54.0) | 31 (62.0) | 37 (74.0) | 0.049 | 0.549 | 0.161 | 0.009 | 0.418 | 0.039 | 0.200 | |
| 2-week follow-up | FD score | 31 (62.0) | 33 (66.0) | 38 (76.0) | 42 (84.0) | 0.049 | 0.173 | 0.133 | 0.016 | 0.272 | 0.041 | 0.320 |
| PDS score | 36 (72.0) | 38 (76.0) | 44 (88.0) | 44 (88.0) | 0.085 | – | – | – | – | – | – | |
| EPS score | 26 (52.0) | 30 (60.0) | 32 (64.0) | 38 (76.0) | 0.092 | – | – | – | – | – | – | |
| 8-week questionnaire survey | FD score | 10 (20.0) | 8 (16.0) | 9 (18.0) | 16 (32.0) | 0.204 | – | – | – | – | – | – |
| PDS score | 12 (24.0) | 16 (32.0) | 18 (36.0) | 19 (38.0) | 0.454 | – | – | – | – | – | – | |
| EPS score | 5 (10.0) | 9 (18.0) | 6 (12.0) | 15 (30.0) | 0.038 | 0.255 | 0.750 | 0.017 | 0.404 | 0.164 | 0.032 | |
All hypothesis tests were two-sided. p < 0.05 was considered significant. Patients in the placebo, positive_control, BL-99_low, and BL-99_high groups were administered with maltodextrin (2 g/day), rabeprazole (10 mg/day), low-dose BL-99 (1 × 1010 CFU/day), and high-dose BL-99 (5 × 1010 CFU/day), respectively. Source data are provided as a Source Data file.
BL-99, Bifidobacterium animalis subsp. lactis BL-99.
aClinical response rate was defined as the proportion of participants with a score (i.e., FD score, PDS score, and EPS score) decrease >0.5.
bFD score: the composite functional dyspepsia score is calculated as the mean of postprandial fullness, early satiety, epigastric pain, and epigastric burning scores.
cPDS score: the postprandial distress syndrome score is calculated as the mean of postprandial fullness score and early satiety score.
dEPS score: the epigastric pain syndrome score is calculated as the mean of epigastric pain score and epigastric burning score.