Table 3.
Within-Group comparison for SBI Groupsa
| Variable | Treatment Group | n Median (Q1-Q3) | P-valuec | |||||
|---|---|---|---|---|---|---|---|---|
| Baseline | LOCFb | Delta | ||||||
| CD4 (cells/uL) | SBI 2.5 g | 54 | 803 (469–958) | 55 | 638 (466–915) | 54 | -38 (-158–67) | 0.018 |
| SBI 5.0 g | 47 | 543 (757–417) | 45 | 567 (413–800) | 45 | 16 (-67–83) | 0.539 | |
| CD4/CD8 | SBI 2.5 g | 54 | 0.76 (0.46–1.42) | 55 | 0.81 (0.47–1.35) | 54 | 0 (-0.06–0.08) | 0.772 |
| SBI 5.0 g | 47 | 0.66 (1–0.48) | 45 | 0.65 (0.51–0.98) | 45 | 0.01 (-0.07–0.06) | 0.760 | |
| I-FABP (ng/μL) | SBI 2.5 g | 54 | 1.95 (0.99–3.11) | 55 | 1.40 (0.79–2.24) | 54 | -0.23 (-1.48–0.24) | 0.023 |
| SBI 5.0 g | 47 | 1.81 (1.10–2.66) | 45 | 1.56 (1–2.10) | 45 | -0.45 (-1.17–0.36) | 0.043 | |
| Zonulin (ng/μL) | SBI 2.5 g | 54 | 34.61 (19.43–42.24) | 55 | 29.25 (20.59–38.24) | 54 | -4.16 (-17.07–6.85) | 0.117 |
| SBI 5.0 g | 47 | 34.27 (24.16–49.35) | 45 | 26.42 (17.33–40.95) | 45 | -6.18 (-21.44–3.03) | 0.009 | |
| Flagellin (ng/μL) | SBI 2.5 g | 54 | 4.34 (2.55–7.16) | 55 | 4.22 (1.83–6.61) | 54 | -0.22 (-2.61–1.55) | 0.307 |
| SBI 5.0 g | 47 | 5.14 (3.15–8.02) | 45 | 5.36 (3.42–7.87) | 45 | -0.07 (-2.66–1.76) | 0.792 | |
| sCD14 (ng/μL) | SBI 2.5 g | 54 | 2.02 (1.70–2.27) | 55 | 1.99 (1.69–2.20) | 54 | -0.08 (-0.29–0.26) | 0.433 |
| SBI 5.0 g | 47 | 1.87 (1.41–2.20) | 45 | 1.79 (1.43–2.05) | 45 | 0 (-0.28–0.21) | 0.675 | |
| IL-6 (pg/μL) | SBI 2.5 g | 54 | 1.72 (1.20–2.71) | 55 | 1.27 (0.65–2.07) | 54 | -0.53 (-1.27–0.25) | 0.012 |
| SBI 5.0 g | 47 | 1.37 (0.91–2.46) | 45 | 1.31 (0.60–2.18) | 45 | -0.38 (-1.13–0.40) | 0.072 | |
a
Analysis population = Patients receiving SBI for 24 weeks and patients crossing-over from PBO to SBI after week 4
b
Last observation carried forward, to 24 weeks for SBI-treated group and to 20 weeks for PBOSBI cross-over group
c
Wilcoxon Signed-Rank test
Abbreviations: SBI, Serum-derived bovine immunoglobulin/protein isolate; LOCF, Last observed carried forward; I-FABP, intestinal fatty acid binding protein; sCD14, soluble CD14