Modified Helicobacter test using a new test meal and a 13C-urea breath test in Helicobacter pylori positive and negative dyspepsia patients on proton pump inhibitors

Table 1 Demographic data n (%)

Demographic variable	n = 114
Age (yr), mean ± SD	51.07 ± 14.4
Height (cm), mean ± SD	168.90 ± 9.3
Weight (kg), mean ± SD	73.43 ± 14.9
BMI (kg/m²), mean ± SD	25.66 ± 4.3
Ethnic group
Caucasian	114 (100.0)
Other	0 (0.0)
Gender
Female	76 (66.7)
Male	38 (33.3)

Table 2 Diagnostic investigation for Helicobacter pylori (n = 114)

Hp diagnostic test	n (%)
UBT with standard test meal
Positive	63 (55.3)
Negative	51 (44.7)
Upper endoscopy
Yes	110 (96.5)
No	4 (3.5)
Culture
Positive	60 (54.5)
Negative	36 (32.7)
Not evaluated	14 (12.7)
Histology
Positive	53 (48.2)
Negative	47 (42.7)
Not evaluated	10 (9.1)
Rapid urease test
Positive	63 (57.3)
Negative	47 (42.7)

Hp: Helicobacter pylori.

Table 3 Thirty days of proton pump inhibitors medication, different cut-off points 2‰, 2.5‰, 3‰, sampling time 30 min

Cut-off	Sensitivity	Specificity	PPV	NPV	Accuracy
2‰	92.45%	97.96%	98.00%	92.31%	95.10%
2.5‰	92.45%	97.96%	98.00%	92.31%	95.10%
3‰	86.79%	97.96%	97.87%	87.27%	92.16%

Table 4 Sensitivity of the ¹³C-urea breath test using the new test meal for Helicobacter pylori n (%)

Population	Result of UBT with new test meal	Diagnosis of Hp infection		Sensitivity	95%CI
		Positive	Negative
ITT (n = 114)	Positive	50 (78.1)	1 (2.0)	78.13%	66.03%-87.49%
	Negative	13 (20.3)	48 (96.0)
	Not performed	1 (1.6)	1 (2.0)
PP (n = 102)	Positive	49 (92.5)	1 (2.0)	92.45%	81.79%-97.91%
	Negative	4 (7.5)	48 (98.0)

UBT: Urea breath test; ITT: Intention-to-treat; PP: Per-protocol; Hp: Helicobacter pylori.

Table 5 Specificity of the ¹³C-urea breath test using the new test meal for Helicobacter pylori n (%)

Population	Result of UBT with new test meal	Diagnosis of Hp infection		Specificity	95%CI
		Positive	Negative
ITT (n = 114)	Positive	50 (78.1)	1 (2.0)	96.00%	86.29%-99.51%
	Negative	13 (20.3)	48 (96.0)
	Not performed	1 (1.6)	1 (2.0)
PP (n = 102)	Positive	49 (92.5)	1 (2.0)	97.96%	89.15%-99.95%
	Negative	4 (7.5)	48 (98.0)

UBT: Urea breath test; ITT: Intention-to-treat; PP: Per-protocol; Hp: Helicobacter pylori.