Table 4.
Clostridioides difficile Health-Related Quality-of-Life Survey Component Scores at Baseline and Week 8 by Treatment Arm and Response Status
| Cdiff32 Domain |
RBL Arm | Placebo Arm | ||||||
|---|---|---|---|---|---|---|---|---|
| Cdiff32 Score, Mean (SD) | P Value | Cdiff32 Score, Mean (SD) | P Value | |||||
| Baseline | wk 8 | Change | Baseline | wk 8 | Change | |||
| Responders (n = 178)a | ||||||||
| Total | 43.7 (17.4) | 75.8 (18.3) | 32.1 (21.4) | <.001* | 42.4 (20.3) | 70.1 (23.2) | 27.7 (19.8) | <.001b |
| Physical | 52.6 (21.1) | 84.2 (16.9) | 31.7 (22.8) | <.001* | 49.9 (22.7) | 79.2 (21.6) | 29.3 (23.2) | <.001b |
| Mental | 32.7 (16.8) | 66.4 (22.0) | 33.7 (24.1) | <.001* | 33.0 (20.5) | 60.1 (27.0) | 27.0 (21.4) | <.001b |
| Social | 53.5 (23.6) | 80.2 (21.3) | 26.6 (27.9) | <.001* | 49.3 (26.5) | 73.6 (27.8) | 24.3 (27.3) | <.001b |
| Nonresponders (n = 7)a | ||||||||
| Total | 61.5 (16.7) | 76.3 (5.9) | 14.8 (16.4) | .42 | 59.0 (31.0) | 57.2 (35.0) | −1.8 (25.6) | .85 |
| Physical | 78.0 (14.9) | 91.1 (4.7) | 13.1 (19.3) | .42 | 62.5 (35.3) | 62.1 (37.8) | −0.5 (30.8) | .86 |
| Mental | 47.0 (19.6) | 60.7 (15.6) | 13.7 (16.2) | .18 | 54.9 (27.7) | 50.0 (33.2) | −4.9 (23.3) | .85 |
| Social | 54.2 (15.7) | 79.2 (3.6) | 25.0 (16.5) | .18 | 60.9 (33.2) | 65.6 (34.8) | 4.7 (22.5) | >.99 |
Abbreviations: Cdiff32, Clostridioides difficile Health-related Quality-of-Life Survey; RBL, fecal microbiota, live-jslm (REBYOTA; Rebiotix); SD, standard deviation.
a
At week 8, 178 patients were classified as responders (125 [97.7%] in the RBL and 53 [93.0%] in the placebo arm), and 7 were classified as nonresponders (3 [2.3%] in the RBL and 4 [7%] in the placebo arm).
b
Significant at P < .05.