Table 3.
Clinical outcomes for subjects in cohorts 2 and 3a
| Outcome | Cohort 2 (n = 15) | Cohort 3, naïve (n = 10) | Combined naïve subjects (n = 35) | Cohort 3, rechallenged (n = 10) |
|---|---|---|---|---|
| No. with diarrhea (%) | 11 (73) | 9 (90) | 28 (80) | 1 (10) |
| No. with moderate or severe diarrhea (%) | 10 (67) | 7 (70) | 25 (71) | 0 |
| Mean [median] incubation period (hr) (range) | 52 [47] (30–95) | 56 [54] (37–88) | 53 [49] (21–95) | 71 |
| Mean [median] maximum diarrhea stool output in 24-h period (g) (range) | 1,039 [550] (219–4,950) | 1,217 [642] (235–3,688) | 1,042 [636] (219–4,950) | 328 |
| Mean [median] diarrhea total stool output (g) (range) | 1,463 [665] (272–5,851) | 1,865 [1,021] (235–5,463) | 1,564 [1,054] (235–5,851) | 328 |
| Mean [median] duration of diarrhea (hr) (range) | 55 [72] (14–95) | 62 [73] (14–88) | 62 [72] (14–143) | 0 |
| Mean [median] of the maximum no. of stools in 24 h (range) | 8 [7] (2–18) | 5 [7] (2–16) | 7 [6] (1–18) | 1 |
| No. of subjects with fever | 3 | 3 | 6 | 0 |
| No. of subjects with vomiting (maximum no. of vomiting episodes) | 6 (3) | 5 (8) | 15 (8) | 1 (3) |
a
Inoculum dose and buffer were 2 × 107 CFU with bicarbonate.