Table 2.
Disposition of study subjects
| Description | Placebo-controlled, double-blind, crossover phase (Day 1 and day 2) |
Open-label phase (Days 3–16) |
Overall (Days 1–16) |
||||
|---|---|---|---|---|---|---|---|
| SBI 5.0 g QD (N) |
SBI 10.0 g QD (N) |
SBI 20.0 g QD (N) |
SBI 5.0 g/day (2.5 g BID) (N) |
SBI 10.0 g/day (5.0 g BID) (N) |
SBI 20.0 g/day (10.0 g BID) (N) |
Study total (N) |
|
| Subjects participating in the study | 18 | 12 | 12 | 14 | 14 | 13 | 42 |
| Subjects completing 2-day double-blind, crossover period | 18 | 12 | 11* | – | – | – | 41* |
| Subjects completing 14-day open-label period | – | – | – | 12#/14 | 14/14 | 13/13 | 39/41 |
| Subjects completing: | |||||||
| Plasma amino acid analysis | 18 | 12 | 11 | – | – | – | 41 |
| Plasma IgG evaluation | 18 | 12 | 11 | 14 | 14 | 13 | 41 |
| Stool IgG evaluation | – | – | – | 7 | 7 | 7 | 21‡ |
Notes: Dosing errors occurred in six subjects during the double-blind, crossover phase. Four subjects assigned to 10 g of SBI received 5 g of SBI and two subjects assigned to 20 g of SBI received 10 g of SBI. These six subjects continued with the assigned dose of SBI during the 14-day, open-label phase of the study. An additional six subjects were added to the 2-day, double-blind, crossover phase.
One subject withdrew consent on day 1 after a single placebo dose; therefore, only 41 of 42 subjects received crossover dose of SBI on day 2.
Two subjects withdrew during the open-label phase due to AEs.
Stool IgG analysis was conducted only on subjects who provided a baseline stool sample prior to receiving an active dose of SBI.
Abbreviations: AE, adverse event; BID, twice daily; IgG, immunoglobulin G; QD, once daily; SBI, serum-derived bovine immunoglobulin/protein isolate.