Table 1.
C. difficile recurrence and any diarrhea event by treatment arm in a phase 2 clinical trial of NTCD-M3 administered at two different doses of 104 and 107 spores for 7 or 14 days vs. placebo for 14 days (Gerding et al., 2015).
| Placebo | 104 × 7d | 107 × 7d | 107 × 14d | All NTCD | ||
|---|---|---|---|---|---|---|
| Number of patients, n | 43 | 41 | 43 | 41 | 125 | |
| CDI recurrence, n (%) | 13 (30) | 6 (15) | 2 (5) | 6 (15) | 14 (11) | |
| p-value* | 0.11 | 0.01 | 0.10 | 0.006 | ||
| CDI recurrence defined by antibacterial use for CDI treatment, n (%) | 14 (33) | 6 (15) | 4 (9) | 7 (17) | 17 (14) | |
| p-value* | 0.07 | 0.02 | 0.14 | 0.009 | ||
| Any event of diarrhea (of any severity) or CDI, n (%) | 33 (77) | 23 (56) | 25 (58) | 23 (56) | 71 (57) | |
| p-value* | 0.05 | 0.09 | 0.02 | 0.020 |
*
p-values adjusted for pre-specified parameters: use of metronidazole vs. vancomycin, and primary episode vs. first recurrence.