Effect of Aspergillus niger prolyl endopeptidase in patients with celiac disease on a long-term gluten-free diet

Table 2 Per-protocol data and analysis

Item	Overall population	Placebo treatment	AN-PEP treatment
Number of patients	37	20	17
Age in yr, median (range)	40 (29-46)	41 (31-48)	39 (28-45)
Females, n (%)	31 (83.8)	17 (85.0)	14 (82.3)
CeD serology in AU/mL, median (IQR)
IgA DGP at baseline	3 (1-5)	2 (1-5)	3 (1-5)
At end of study	3 (2-6)	3 (2-5)	3 (2-6)
IgA tTG at baseline	17 (7-43)	13 (6-36)	17 (11-48)
End of study	12 (6-48)	11 (5-20)	17 (7-62)
SCI global score at randomization median score (IQR)	36.0 (31.0-44.0)	35.0 (30.0-45.5)	40.0 (33.0-44.0)
End of the study median score (IQR)	33.0 (28.0-39.0)	32.0 (28.5-37.5)	35.0 (28.0-41.0)
SCI scores > 38 at randomization, n (%)	17 (45.9)	7 (35.0)	10 (58.8)
End of study, n (%)	10 (27.0)	5 (25.0)	5 (29.4)a
Stool GIP median and CI (IQR) of the average concentration for period, µg/g
Run-in period	0.40 (0-0.86)	0.37 (0-0.73)	0.55 (0-0.93)
Treatment period	0.30 (0.10-0.80)b	0.25 (0.11-0.79)c	0.32 (0-0.89)d

^aComparison with run-in (McNemar test): P < 0.03.

^bComparison with run-in values P (Wilcoxon): P = 0.43.

^cComparison with run-in values P (Wilcoxon): P = 0.79.

^dComparison with run-in values P (Wilcoxon): P = 0.33.

CeD: Celiac disease; CSI: Celiac symptom index; DGP: Deamidated gliadin peptide antibodies; GIP: Gliadin immunogenic peptides; IQR: Interquartile range; tTG: Tissue transgluteminase antibodies.