Consumption of gluten with gluten-degrading enzyme by celiac patients: A pilot-study

Table 1 Demographic and baseline characteristics of the safety and efficacy phase

	Safety phase	Efficacy phase
	Gluten + AN-PEP	Gluten + placebo	Gluten + AN-PEP
	(n = 16)	(n = 7)	(n = 7)
Patients (n)	16	7	7
Gender (female:male)	12:4	5:2	6:1
Median age at inclusion, yr (range)	55 (20-68)	44 (20-68)	57 (30-64)
Median age at diagnosis, yr (range)	44.5 (0-62)	29 (0-62)	49 (26-53)
Median time on a GFD, yr (range)	7.5 (2-40)	9 (2-40)	8 (4-12)
HLA class (n)
DQ2/X	12	5	5
DQ2/DQ2	2	1	1
DQ2/DQ8	1	0	1
Unknown	1	1	0
Marsh at inclusion (n)
Marsh 0	10	4	3
Marsh I	6	3	4
Gastrointestinal symptoms
Abnormal bowel sounds	4	0	2
Abdominal pain	5	3	2
Bowel distension	5	3	1
Change of defecation	4	2	6
Constipation	3	2	0
Diarrhoea	3	1	1
Dysgeusia	1	1	0
Flatulence	6	1	2
Nausea	4	2	0
Reflux	2	0	1
Vomiting	1	1	0
Weight loss	0	1	0
Total number of symptoms	38	17	15

GFD: Gluten-free diet; AN-PEP: Aspergillus niger prolyl endoprotease.

Table 2 Serum antibodies, duodenal immunohistology and tTGA-A antibody deposits in the safety and efficacy phase for all patients

	Baseline						Safety phase						Efficacy phase
							2 wk gluten + AN-PEP						2 wk gluten + AN-PEP or placebo
	Serum				Biopsy		Tx	Serum				Biopsy	Tx	Serum				Biopsy
	IgA-tTG	IgA-AG	IgG-AG	IgA/G-DGP-tTG	Marsh	IgA-tTG deposits		IgA-tTG	IgA-AG	IgG-AG	IgA/G-DGP-tTG	Marsh		IgA-tTG	IgA-AG	IgG-AG	IgA/G-DGP-tTG	Marsh	IgA-tTG deposits
1	-	-	-	-	I	ND	A	-	-	-	-	0	P	-	-	-	-	I	0
2	-	+/-	-	-	0	0	A	-	+	-	-	I	P	-	++	+	-	IIIA	1-2
3	-	-	-	-	I	0	A	-	-	-	-	I	P	-	-	-	-	IIIA	1-2
4	+/-	-	-	+	I	1	A	-	-	-	+	0	P	+	-	-	++	I	2-3
5	-	-	-	-	0	ND	A	-	-	-	-	0	P	-	-	-	-	0	0
6	-	-	-	-	0	0	A	-	-	-	-	0	P	-	-	-	-	0	1
7	-	-	-	-	0	0	A	-	-	-	-	0	P	-	-	-	-	I	1-2
8	-	-	-	-	I	ND	A	-	-	-	-	II	A	-	-	-	-	I	0
9	-	-	-	-	0	3	A	-	-	-	-	I	A	-	+/-	-	+	I	1
10	-	-	-	-	0	ND	A	-	+/-	-	-	I	A	-	+/-	+	+	I	0
11	-	-	-	-	I	0	A	-	+	-	-	II	A	-	+/-	-	-	IIIA	1
12	-	-	-	-	I	ND	A	-	-	-	-	I	A	-	-	-	-	I	0
13	-	-	-	-	0	ND	A	-	-	-	-	0	A	-	-	-	-	0	0
14	-	-	-	-	0	ND	A	-	-	-	-	0	A	-	-	-	-	0	0
15	-	-	-	++	0	ND	A	-	-	-	++	II	E	-	-	-	++	IIIA	ND
16	-	-	-	-	0	ND	A	-	-	-	-	IIIA	E	-	-	-	-	0	ND

The serum EMA-A antibodies remained negative in all patients during the entire study. Mucosal tTGA-A deposits were graded from 0 to 3. Tx: Treatment; A: AN-PEP; P: Placebo; E: Excluded; IgA-tTG: Anti-tissue transglutaminase IgA antibodies; IgA-GA: Anti-gliadin IgA antibodies; IgG-GA: Anti-gliadin IgG antibodies; IgA/G-DGP-tTG: Anti-tissue transglutaminase and deamidated gliadin-derived peptide IgA and IgG antibodies; I-FABP: Intestinal fatty acid binding protein; ND: Not determined. -: Negative; +/-: Dubious; +: Weak positive; ++: Positive; +++: Strong positive.