Supplemental Table 1. Results of the Diagnostic Test vs. Sex
SexDiagnostic tests
Female (n = 136)
Male
(n = 69) P value
Biopsy, n (%)
Positive 70 (51.5) 38 (55.1) 0.66
Negative 66 (48.5) 31 (44.9)
Gaxilose 4-h urine test, n (%)
Positive 69 (50.7) 36 (52.2) 0.88
Negative 67 (49.3) 33 (47.8)
Gaxilose 5-h urine test, n (%)
Positive 71 (52.2) 38 (55.1) 0.77
Negative 65 (47.8) 31 (44.9)
Gaxilose blood test, n (%)
Positive 69 (50.7) 37 (53.6) 0.77
Negative 66 (48.5) 31 (44.9)
Not done 1 (0.7) 1 (1.4)
Hydrogen breath test, n (%)
Positive 63 (46.3) 30 (43.5) 0.77
Negative 73 (53.7) 39 (56.5)
Glucose blood test, n (%)
Positive 63 (46.3) 33 (47.8) 0.88
Negative 73 (57.7) 36 (52.2)
Admission
All Patients (n = 226)
Efficacy population*
(n = 205)
Conditions, n (%)
Celiac disease 9 (4.0) 8 (3.9)
Irritable bowel syndrome 8 (3.5) 8 (3.9)
Gastroesophageal reflux disease 8 (3.5) 7 (3.4)
Hiatus hernia 7 (3.1) 5 (2.4)
Gastritis 6 (2.7) 6 (2.9)
Ulcerative colitis 6 (2.7) 4 (2.0)
Indeterminate Colitis 4 (1.7) 4 (2.0)
Functional Dyspepsia 3 (1.3) 3 (1.5)
Crohn disease 3 (1.3) 3 (1.5)
Umbilical hernia 2 (0.9) 1 (0.5)
Anal fissure 1 (0.4) 1 (0.5)
Collagenous colitis 1 (0.4) 1 (0.5)
Inguinal hernia 1 (0.4) 1 (0.5)
*Patients included in the efficacy analysis (valid results for at least the gaxilose urine test and intestinal biopsy).
Supplemental Table 3. Results of the Diagnostic Tests in Patients with Other Gastrointestinal Conditions*
Condition Biopsy†
Gaxilose 4-h Urine Test‡
Gaxilose 5-h Urine Test‡
Gaxilose Blood Test‡
Hydrogen Breath Test§
Glucose Blood Test¶
Genetic Test
Celiac disease
H01 15.34 (-)** 59.660 (-) 68.604 (-) 1.270 (-) 2 (-) 32 (-) ND
H07 19.35 (-) 59.849 (-) 79.765 (-) 1.084 (-) 12 (-) 20 (+) ND
H17 27.56 (-) 28.966 (-) 47.407 (-) 1.032 (-) 0 (-) 16 (+) ND
I33 11.63 (-) 48.189 (-) 64.130 (-) 2.591 (-) 5 (-) 53 (-) TT-AA (-)
I44 19.48 (-) 45.966 (-) 60.043 (-) 2.062 (-) 3 (-) 26 (-) ND
I55 17.26 (-) 27.558 (+) 34.406 (+) 0.257 (+) 55 (+) 11 (+) CC-GG (+)
H06 6.27 (+) 17.525 (+) 21.108 (+) 0.537(+) 55 (+) 0 (+) ND
I86 9.94 (+) 11.342 (+) 17.525 (+) 0.652 (+) 3 (-) 27 (-) ND
A15†† 4.73 (+) 25.684 (+) 31.207 (+) 0.529 (+) 24 (+) 5 (+) TT-AA (-)
A24†† 4.68 (+) 18.012 (+) 21.136 (+) 0.390 (+) 77 (+) 0 (+) CC-GG (+)
C02†† 4.85 (+) 27.230 (+) 31.392 (+) 0.964 (+) 10 (-) 66 (-) CT-GA (-)
C05†† 4.95 (+) 17.560 (+) 23.100 (+) 0.682 (+) 74 (+) 6 (+) CC-GG (+)
Irritable bowel syndrome
G06 34.81 (-) 61.620 (-) 70.875 (-) 2.043 (-) 51 (+) 24 (+) CT-GA (-)
(continued)
Supplemental Table 3. (continued)
I54 35.82 (-) 31.757 (-) 38.862 (-) 1.171 (-) 6 (-) 43 (-) CT-GA (-) A17 9.46 (+) 25.479 (+) 33.086 (+) 0.909 (+) 24 (+) 50 (-) CT-GA (-) A19 9.97 (+) 26.402 (+) 36.728 (+) 0.864 (+) 21 (+) 59 (-) CT-GA (-)
C38 8.52 (+) 19.893 (+) 23.552 (+) 0.586 (+) 69 (+) 0 (+) CC-GG (+)
H05 7.50 (+) 19.316 (+) 26.602 (+) 0.796 (+) 72 (+) 16 (+) ND
I48 7.38 (+) 27.045 (+) 33.562 (+) 0.796 (+) 36 (+) 10 (+) CC-GG (+) J02 9.09 (+) 24.971 (+) 29.244 (+) 0.383 (+) 162 (+) 1 (+) CC-GG (+)
Ulcerative colitis
A20 9.78 (+) 27.204 (+) 35.842 (+) 0.848 (+) 10 (-) 32 (-) CT-GA (-) I23 8.82 (+) 25.659 (+) 32.249 (+) 0.423 (+) 102 (+) 10 (+) CC-GG (+) I40 8.90 (+) 27.204 (+) 31.734 (+) 0.913 (+) 14 (-) 26 (-) TT-AA (-) I75 14.74 (-) 32.808 (-) 38.606 (-) 0.982 (-) 6 (-) 15 (+) CC-GG (+) I68†† 9.96 (+) 25.976 (+) 36.780 (+) 0.334 (+) 0 (-) 20 (+) TT-AA (-)
Crohn disease
A04 22.68 (-) 32.075 (-) 42.580 (-) 1.275 (-) 4 (-) 34 (-) CT-GA (-) I13 10.51 (-) 28.878 (-) 38.091 (-) 1.063 (-) 15 (-) 21 (+) CT-GA (-) I32 13.90 (-) 34.343 (-) 38.313 (-) 1.059 (-) 0 (-) 26 (-) CT-GA (-) I37†† 6.69 (+) 25.115 (+) 33.100 (+) 0.483 (+) 0 (-) 33 (-) CT-GA (-)
(continued)
Supplemental Table 3. (continued)
Indeterminate colitis
H01 15.34 (-) 59.660 (-) 68.604 (-) 1.270 (-) 2 (-) 32 (-) ND
A31 3.93 (+) 23.983 (+) 27.348 (+) 0.615 (+) 40 (+) 19 (+) CC-GG (+) I60 9.61 (+) 23.445 (+) 30.301 (+) 0.568 (+) 35 (+) 23 (+) CC-GG (+)
J01 5.06 (+) 25.871 (+) 29.900 (+) 0.410 (+) 97 (+) 5 (+) CC-GG (+)
Collagenous colitis
I67 8.45 (+) 26.231 (+) 37.250 (+) 0.559 (+) 94 (+) 22 (+) CC-GG (+)
*Patients with the indicated condition are listed by their patient number. †The cut-off value of lactase-activity measured in duodenal biopsy material was 10 U/g protein.7 ‡The cut-off values of D-xylose for the gaxilose tests were 27.58 and 37.87 mg for the 4-h and 5-h urine tests, respectively, and 0.97 mg/dL for the blood test, as determined in Phase I/Ib Studies. 25 §The cut-off value for the H2 breath test was 20 ppm.7
¶The cut-off value for the capillary-blood glucose test was 25 mg/dL.7 Genotypes of single nucleotide polymorphisms C/T–13910-G/A–22018 are associated with genetically-determined adult hypolactasia.15,16 **Positive (+) and negative (-) results are indicated for simplicity. ††Patients diagnosed in the follow-up visits.
