Noninvasive diagnosis of hypolactasia with 4-galactosylxylose (gaxilose): A multicentre, open-label, phase IIB-III nonrandomized trial

Journal of Clinical Gastroenterology

Volumn 48, Issue 1, 2014, Pages 29-36

  Aragón, Juan J ^a   Hermida, Carmen ^a,b   Martínez Costa, Oscar H ^a   Sánchez, Valentina ^a   Martín, Igor ^c   Sánchez, José J ^d   Codoceo, Rosa ^e   Cano, José M ^f   Cano, Ana ^g   Crespo, Laura ^g   Torres, Yolanda ^j   García, Francisco J ^j   Fernández Mayoralas, Alfonso ^h   Solera, Jesús ⁱ   Martínez, Pilar ⁱ  

^a INSTITUTO DE INVESTIGACIONES BIOMÉDICAS ALBERTO SOLS   (Spain)

^b NOVOZYMES A S   (Denmark)

^c Clinica SAS   (Spain)

^d AUTONOMOUS UNIVERSITY OF MADRID   (Spain)

^e Centro Médico D Medical   (Spain)

^f HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^g HOSPITAL RAMÓN Y CAJAL   (Spain)

^h INSTITUTO DE QUÍMICA ORGÁNICA GENERAL   (Spain)

ⁱ HOSPITAL UNIVERSITARIO LA PAZ IDIPAZ   (Spain)

^j HOSPITAL SAN JUAN DE DIOS DEL ALJARAFE   (Spain)

more..

Author keywords

4 galactosylxylose; diagnostic test; gaxilose; hypolactasia; intestinal lactase; lactose intolerance

Indexed keywords

GAXILOSE; GLUCOSE; LACTASE; LACTOSE; XYLOSE;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST; DIAGNOSTIC TEST ACCURACY STUDY; DIARRHEA; DRUG WITHDRAWAL; FEMALE; GASTROENTERITIS; GENETIC SCREENING; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; HUMAN TISSUE; INTESTINE BIOPSY; LACTASE DEFICIENCY; LACTOSE INTOLERANCE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MONITOR; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PORTABLE EQUIPMENT; PREDICTIVE VALUE; PRIORITY JOURNAL; RECEIVER OPERATING CHARACTERISTIC; SENSITIVITY AND SPECIFICITY; SINGLE BLIND PROCEDURE; URINALYSIS; URTICARIA; VOMITING; YOUNG ADULT;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; BLOOD GLUCOSE; BREATH TESTS; DISACCHARIDES; FEMALE; GENETIC TESTING; HUMANS; LACTASE; LACTOSE INTOLERANCE; MALE; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; PROSPECTIVE STUDIES; REPRODUCIBILITY OF RESULTS; ROC CURVE; SENSITIVITY AND SPECIFICITY; TIME FACTORS; XYLOSE; YOUNG ADULT;

EID: 84891560499     PISSN: 01920790     EISSN: 15392031     Source Type: Journal    
DOI: 10.1097/MCG.0b013e318297fb10     Document Type: Article

References (35)

1. Semenza G, Auricchio S, Mantei N. Small-intestinal disac-charidases. Available at: http://dx.doi.org/10.1036/ommbid.95. Accessed February 29, 2012. In: Valle D, Beaudet AL, Vogelstein B, et al, eds. Scriver's Online Metabolic and Molecular Bases of Inherited Disease. New York: McGraw-Hill; 2006.
2. Sahi T. Genetics and epidemiology of adult-type hypolactasia. Scand J Gastroenterol. 1994;202:7-20.
3. Swallow DM, Hollox EJ. Genetic polymorphism of intestinal lactase activity in adult humans. Available at: http://dx.doi.org/10.1036/ommbid.96. Accessed February 29, 2012. In: Valle D, Beaudet AL, Vogelstein B, et al, eds. Scriver's Online Metabolic and Molecular Bases of Inherited Disease. New York: McGraw-Hill; 2006.
4. Swagerty DL Jr, Walling AD, Klein RM. Lactose intolerance. Am Fam Physician. 2002;65:1845-1850.
5. Lifshitz F. Congenital lactase deficiency. J Pediatr. 1966;69: 229-237.
6. Newcomer AD, McGill DB. Clinical importance of lactase deficiency. N Engl J Med. 1984;310:42-43.
7. Arola H. Diagnosis of hypolactasia and lactose malabsorption. Scand J Gastroenterol. 1994;202:26-35.
8. Jarvela I, Torniainen S, Kolho KL. Molecular genetics of human lactase deficiencies. Ann Med. 2009;41:568-575.
9. Suarez FL, Savaiano DA, Levitt MD. A comparison of symptoms after the consumption of milk or lactose-hydrolyzed milk by people with self-reported severe lactose intolerance. N Engl J Med. 1995;333:1-4.
10. Newcomer AD, McGill DB, Thomas PJ, et al. Prospective comparison of indirect methods for detecting lactase deficiency. N Engl J Med. 1975;293:1232-1236.
11. Simren M, Stotzer PO. Use and abuse of hydrogen breath tests. Gut. 2006;55:297-303.
12. 2 breath test. Scand J Gastroenterol. 1999;34:35-40.
13. 13C-lactose digestion test. Eur J Clin Invest. 2000;30:140-146.
14. 2H-glucose test for determination of small intestinal lactase activity. Eur J Clin Invest. 2001;31:226-233.
15. Enattah NS, Sahi T, Savilahti E, et al. Identification of a variant associated with adult-type hypolactasia. Nat Genet. 2002;30:233-237.
16. Kerber M, Oberkanins C, Kriegshauser G, et al. Hydrogen breath testing vs. LCT genotyping for the diagnosis of lactose intolerance: a matter of age? Clin Chim Acta. 2007;383:91-96.
17. Ingram CJE, Elamin MF, Mulcare CA, et al. A novel polymorphism associated with lactose tolerance in Africa: multiple causes for lactase persistence? Hum Genet. 2007; 120:779-788.
18. Dawson DJ, Lobley RW, Burrows PC, et al. Lactose digestion by human jejunal biopsies: the relationship between hydrolysis and absorption. Gut. 1986;27:521-527.
19. Suchy FJ, Brannon PM, Carpenter TO, et al. National Institutes of Health Consensus Development Conference: lactose intolerance and health. Ann Intern Med. 2010;152: 792-796.
20. Aragon JJ, Fernandez-Mayoralas A, Jimenez-Barbero J, et al. Evaluation of rat intestinal lactase in vivo with 4-galactosylxy-lose. Clin Chim Acta. 1992;210:221-226.
21. Hermida C, Corrales G, Martinez-Costa OH, et al. Non-invasive evaluation of intestinal lactase with 4-galactosylxylose: comparison with 3-and 2-galactosylxylose and optimization of the method in rats. Clin Chem. 2006;52:270-277.
22. Ohkohchi N, Himukai M, Igarashi Y, et al. Mechanism of D-xylose transport in human small intestine. J Pediatr Gastro-enterol Nutr. 1986;5:372-378
23. Craig RM, Ehrenpreis ED. D-xylose testing. J Clin Gastro-enterol. 1999;29:143-150.
24. Eberts TJ, Sample RHB, Glick MR, et al. A simplified, colorimetric micromethod for xylose in serum or urine, with phloroglucinol. Clin Chem. 1979;25:1440-1443.
25. Hermida C, Guerra P, Martinez-Costa OH, et al. Phase I and phase Ib clinical trials for the noninvasive evaluation of intestinal lactase with 4-galactosylxylose (gaxilose). J Clin Gastroenterol. 2013. Doi: 10.1097/MCG.0b013e318272f507.
26. Dahlqvist A. Assay of intestinal disaccharidases. Scand J Clin Lab Invest. 1964;44:169-172.
27. Hermida C, Corrales G, Canada FJ, et al. Optimizing the enzymatic synthesis of beta-D-galactopyranosyl-D-xyloses for their use in the evaluation of lactase activity in vivo. Bioorg Med Chem. 2007;15:4836-4840.
28. 13C-enriched lactose for detection of lactase deficiency in patients with gastrointestinal symptoms. J Lab Clin Med. 1988;112:193-200.
29. DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: A nonparametric approach. Biometrics. 1988;44:837-845.
30. 2-breath testing in gastrointestinal diseases: The Rome Consensus Conference. Aliment Pharmacol Ther. 2009;29(suppl 1):1-49.
31. Savaiano DA, Boushey CJ, McCabe GP. Lactose intolerance symptoms assessed by meta-analysis: a grain of truth that leads to exaggeration. J Nutr. 2006;136:1107-1113.
32. Heyman MB, Committee on Nutrition. Lactose intolerance in infants, children, and adolescents. Pediatrics. 2006;118:1279-1286.
33. Buchowski MS, Semenya J, Johnson AO. Dietary calcium intake in lactose maldigesting intolerant and tolerant African-American women. J Am Coll Nutr. 2002;21:47-54.
34. Triadou N, Bataille J, Schmitz J. Longitudinal study of the human intestinal brush border membrane proteins. Distribution of the main disaccharidases and peptidases. Gastro-enterology. 1983;85:1326-1332.
35. Maiuri L, Rossi M, Raia V, et al. Morphological method for the diagnosis of human adult type hypolactasia. Gut. 1994;35:1042-1046.