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

doi:10.3748/wjg.v30.i11.1545

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World Journal of Gastroenterology

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1007-9327

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Clinical Trials Study

World J Gastroenterol. Mar 21, 2024; 30(11): 1545-1555
Published online Mar 21, 2024. doi: 10.3748/wjg.v30.i11.1545

Table 1 Patient data collected in the study in the intention-to-treat analysis

Item	Overall population	Placebo treatment	AN-PEP treatment
Number of patients	40	21	19
Age in yr, median (range)	40.5 (29-47)	42.0 (32-48)	39.0 (28-46)
Females, n (%)	33.0 (82.5)	18.0 (85.7)	15.0 (78.9)
CeD serology in U/mL, median (IQR)
IgA DGP at baseline	3.0 (1.3-5.0)	2.0 (1.0-5.0)	4.0 (2.0-5.0)
End of study	3 (2-6)	3 (2-5)	3 (2-6)
IgA tTG at baseline	17 (7-44)	10 (5-30)	17 (8-49)
End of study	12 (6-50)	11 (6-15)	17 (8-70)
SCI global score at randomization median score (IQR)	36 (32-44)	35 (30-44)	40 (33-44)
End of the study median score (IQR)	34 (28-40)	32 (29-39)	35 (28-41)
SCI scores > 38 at randomization, n (%)	19 (47.5)	8 (38.1)	11 (57.9)
End of the study, n (%)	12 (30.0)	6 (28.6)	6 (31.6)^a
Stool GIP. Median and CI (IQR) of the average concentration for period (µg/g)
Run-in period	0.37 (0-0.83)^d	0.34 (0-0.68)^b	0.42 (0-0.93)^c
Treatment period	0.21 (0-0.79)^d	0.19 (0.11-0.79)^b	0.22 (0-0.89)^c

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

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

^cComparison with run-in values P (Wilcoxon): P = 0.19.

^dComparison with run-in values P (Wilcoxon): P = 0.29.

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

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.

Table 3 Quality of life data from the Short Form-36 questionnaire on the intention-to-treat analysis

Item	Placebo arm		AN-PEP arm
Item	At baseline	Final	At baseline	Final
Number of patients	21		19
General health
Median score (IQR)	65 (50-72)	70 (50-80)^b	50 (35-75)	50 (40-80)
Pain
Median score (IQR)	80 (42-90)	90 (50-80)^b	80 (45-90)	67.5 (47.5-90.0)^a
Vitality
Median score (IQR)	60 (45-65)	60 (50-70)	40 (30-60)	55 (40-65)^c
Mental health
Median score (IQR)	68 (52-72)	68 (56-80)	68 (40-72)	64 (48-80)
Physical function
Median score (IQR)	95 (75-100)	95 (75-100)	95 (85-100)	100 (90-100)
Social function
Median score (IQR)	75 (50-100)	100 (62.5-100.0)	50 (37-100)	75 (50-100)
Physical limitations
Median score (IQR)	100 (50-100)	100 (75-100)	100 (25-100)	75 (25-100)
Emotional limitations
Median score (IQR)	50 (0-100)	100 (66-100)^b	66.7 (0-100)	66.7 (0-100)

^avs placebo: P < 0.05.

^bRun-in vs treatment: P < 0.05.

^cRun-in vs treatment: P < 0.005.

AN-PEP: Aspergillus niger prolyl endopeptidase protease; IQR: Interquartile range.

Citation: Stefanolo JP, Segura V, Grizzuti M, Heredia A, Comino I, Costa AF, Puebla R, Temprano MP, Niveloni SI, de Diego G, Oregui ME, Smecuol EG, de Marzi MC, Verdú EF, Sousa C, Bai JC. Effect of Aspergillus niger prolyl endopeptidase in patients with celiac disease on a long-term gluten-free diet. World J Gastroenterol 2024; 30(11): 1545-1555
URL: https://www.wjgnet.com/1007-9327/full/v30/i11/1545.htm
DOI: https://dx.doi.org/10.3748/wjg.v30.i11.1545