Table 1.
Characteristics of the study participants with changes in fecal calprotectin from baseline to week 8 (n = 29).
| Cohort with an Increase in Fecal Calprotectin at Week 8 (n = 13) Median (IQR) |
Cohort with a Decrease in Fecal Calprotectin at Week 8 (n = 16) Median (IQR) |
p-Value | ||||||
|---|---|---|---|---|---|---|---|---|
| Patient Characteristics | ||||||||
| Male, n (%) | 4 (31%) | 11 (69%) | 0.07 # | |||||
| Age (years) | 39 (31.0–47.0) | 31 (27.0–43.5) | 0.25 a | |||||
|
Body mass index
(Kg/m2) |
25.2 (24.3–27.3) (n = 12) | 25.4 (23.8–28.1) (n = 14) | 0.72 a | |||||
| Total Mayo Score | 6.0 (4.0–7.0) (n = 9) | 6.5 (5.0–7.0) (n = 10) | 0.77 a | |||||
| Partial Mayo Score | 2 (1–4) | 3 (1–5) (n = 15) | 0.73 a | |||||
| Partial Mayo Score by disease activity | ||||||||
| Remission, n (%) | 6 (46%) | 4 (27%) | 0.55 ^ | |||||
| Mild, n (%) | 4 (31%) | 7 (47%) | 0.60 ^ | |||||
| Moderate, n (%) | 2 (15%) | 2 (13%) | 0.95 ^ | |||||
| Severe, n (%) | 1 (8%) | 2 (13%) | n/a ^ | |||||
| Medical Therapy | ||||||||
|
5-ASA monotherapy
n (%) |
5 (38%) | 7 (44%) | 0.24 # | |||||
|
Anti-TNF
n (%) |
3 (23%) | 4 (25%) | 1.00 # | |||||
|
Corticosteroid
n (%) * |
3 (25%) (n = 12) | 6 (38%) | 0.69 # | |||||
| Immunomodulator, n (%) * | 1 (8%) | 2 (13%) | 1.00 # | |||||
|
Probiotics
n (%) * |
4 (31%) | 3 (19%) | 0.67 # | |||||
| Fecal Calprotectin (FCP) | ||||||||
| Baseline | Week 8 | p-value | Baseline | Week 8 | p-value | Baseline | Week 8 | |
| FCP (mcg/g) | 56.3 (0–551) |
961 (217–2436) |
0.001 b | 1177 (167–2636) |
53 (0–415) |
<0.001 b | 0.02 a | 0.01 a |
|
FCP < 100, remission
n (%) †,^ |
8 (62%) | 1 (8%) | 0.31 | 3 (19%) | 9 (56%) | 0.27 | 0.20 | n/a |
|
FCP 100–250,
grey zone n (%) †,^ |
0 | 3 (23%) | n/a | 4 (25%) | 2 (13%) | 0.74 | n/a | 0.78 |
|
FCP > 250,
active n (%) †,^ |
5 (38%) | 9 (69%) | 0.2 | 9 (56%) | 5 (31%) | 0.37 | 0.52 | 0.17 |
Abbreviations: 5-ASA:5-aminosalicylic acids; Anti-TNF: anti-tumor necrosis factor. * used concomitantly with other therapies, † based on the International Organization for the Study of IBD guidelines [20] # Fisher’s exact test; ^ test of proportions, n/a = insufficient counts; a Mann–Whitney test; b Wilcoxon signed-rank test.