Back to resultsEvaluation of LacTEST for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance
Primary Purpose
Lactose Intolerance
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
gaxilose
lactose
Sponsored by
About this trial
This is an interventional diagnostic trial for Lactose Intolerance
Eligibility Criteria
Inclusion Criteria:
- Adults of either sex, between 18 and 70 years old.
- Capacity for understanding and giving the informed consent to participate in this study.
- Patients with clinical suggestive of lactose intolerance, primary or secondary, who have not been diagnosed and that fulfil the requirements allowed by the gaxilose summary of product characteristics (SmPC).
Exclusion Criteria:
- Pregnant women or breast-feeding women.
- Unable or reticent to give the informed consent or to comply with the study requirements.
- Patients with glomerular filtration rate (GFR) less than 90 ml/min/1.73m2.
- Portal hypertension: ascites, cirrhosis.
- Medical records of total gastrectomy and/or vagotomy.
- Patients diagnosed with myxedema.
- Patients with Diabetes Mellitus.
- Patients who are participating or have participated in any clinical trial within the 3 months previous to their inclusion in the study.
- Patients who are drug abuse consumers.
- Patients under treatment with antibiotics, sulphamides and antiparasitics, who cannot suspend the treatments 7 days prior to the performance of the hydrogen breath test.
- Patients with any recognized and already existing disorder that might interfere with the any of the lactose intolerance diagnosis tests.
- Patients who have taken aspirin of indomethacin in the 48h preceding the performance of the Gaxilose test.
Sites / Locations
- Hospital Universitario Marqués de Valdecilla
- Hospital Universitario de Getafe
- Hospital Universitario Doctor Josep Trueta
- Hospital Universitario de La Princesa
- Hospital Universitario Ramón y Cajal
- Hospital Universitario Virgen de la Victoria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LacTEST
Hydrogen Breath Test
Arm Description
0,45 g of gaxilose po, once, per diagnostic test performed.
25 to 50 g of lactose po, once, per diagnostic test performed.
Outcomes
Primary Outcome Measures
Visual Analogical Scale
The primary objective is to demonstrate non-inferiority of gaxilose test, compared with Hydrogen Breath Test (HBT) using a validated method (VAS results pre and post-test), on the impact on diagnostic thinking for the diagnosis of hypolactasia.
Secondary Outcome Measures
Physician's Questionnaire
To demonstrate non-inferiority of gaxilose test, compared with Hydrogen Breath Test (HBT), on the impact on patient management for the diagnosis of hypolactasia, through a Physician's Qestionnaire.
Intraclass Correlation Coefficient
To demonstrate gaxilose test reproducibility [ICC (2,1)] with urine accumulated from 0-4h after gaxilose administration, and with urine accumulated from 0-5h after gaxilose administration.
Number of participants with treatment-related adverse events as assessed by the most recent version of MedDRA thesaurus.
To assess the safety profile of both tests performed, by assessing the frecuency of treatment-related AEs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02636413
Brief Title
Evaluation of LacTEST for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance
Official Title
Evaluation of the Impact of LacTEST on Diagnostic Thinking and on Patient Management, and of the Reproducibility (Test-Retest), for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VenterPharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate both the impact of LacTEST on diagnostic thinking and on patient management, and its reproducibility (Test-Retest), for the diagnosis of hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose intolerance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactose Intolerance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LacTEST
Arm Type
Experimental
Arm Description
0,45 g of gaxilose po, once, per diagnostic test performed.
Arm Title
Hydrogen Breath Test
Arm Type
Active Comparator
Arm Description
25 to 50 g of lactose po, once, per diagnostic test performed.
Intervention Type
Drug
Intervention Name(s)
gaxilose
Other Intervention Name(s)
LacTEST
Intervention Description
After gaxilose administration, urine collection, cuantification (firstly from 0 to 4 hours, and total urine from 0 to 5 hours), and xilose cuantification afterwards.
Intervention Type
Dietary Supplement
Intervention Name(s)
lactose
Other Intervention Name(s)
Hydrogen Breath Test (HBT)
Intervention Description
After lactose administration, expired hydrogen measurement at pre-specified intervals.
Primary Outcome Measure Information:
Title
Visual Analogical Scale
Description
The primary objective is to demonstrate non-inferiority of gaxilose test, compared with Hydrogen Breath Test (HBT) using a validated method (VAS results pre and post-test), on the impact on diagnostic thinking for the diagnosis of hypolactasia.
Time Frame
Through study completion, up to 10 months.
Secondary Outcome Measure Information:
Title
Physician's Questionnaire
Description
To demonstrate non-inferiority of gaxilose test, compared with Hydrogen Breath Test (HBT), on the impact on patient management for the diagnosis of hypolactasia, through a Physician's Qestionnaire.
Time Frame
Through study completion, up to 10 months.
Title
Intraclass Correlation Coefficient
Description
To demonstrate gaxilose test reproducibility [ICC (2,1)] with urine accumulated from 0-4h after gaxilose administration, and with urine accumulated from 0-5h after gaxilose administration.
Time Frame
Through study completion, up to 10 months.
Title
Number of participants with treatment-related adverse events as assessed by the most recent version of MedDRA thesaurus.
Description
To assess the safety profile of both tests performed, by assessing the frecuency of treatment-related AEs.
Time Frame
Through study completion, up to 10 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults of either sex, between 18 and 70 years old.
Capacity for understanding and giving the informed consent to participate in this study.
Patients with clinical suggestive of lactose intolerance, primary or secondary, who have not been diagnosed and that fulfil the requirements allowed by the gaxilose summary of product characteristics (SmPC).
Exclusion Criteria:
Pregnant women or breast-feeding women.
Unable or reticent to give the informed consent or to comply with the study requirements.
Patients with glomerular filtration rate (GFR) less than 90 ml/min/1.73m2.
Portal hypertension: ascites, cirrhosis.
Medical records of total gastrectomy and/or vagotomy.
Patients diagnosed with myxedema.
Patients with Diabetes Mellitus.
Patients who are participating or have participated in any clinical trial within the 3 months previous to their inclusion in the study.
Patients who are drug abuse consumers.
Patients under treatment with antibiotics, sulphamides and antiparasitics, who cannot suspend the treatments 7 days prior to the performance of the hydrogen breath test.
Patients with any recognized and already existing disorder that might interfere with the any of the lactose intolerance diagnosis tests.
Patients who have taken aspirin of indomethacin in the 48h preceding the performance of the Gaxilose test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Crespo, MD, PhD
Organizational Affiliation
Hospital Universitario Ramón y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario de Getafe
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Hospital Universitario Doctor Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23722657
Citation
Aragon JJ, Hermida C, Martinez-Costa OH, Sanchez V, Martin I, Sanchez JJ, Codoceo R, Cano JM, Cano A, Crespo L, Torres Y, Garcia FJ, Fernandez-Mayoralas A, Solera J, Martinez P. Noninvasive diagnosis of hypolactasia with 4-Galactosylxylose (Gaxilose): a multicentre, open-label, phase IIB-III nonrandomized trial. J Clin Gastroenterol. 2014 Jan;48(1):29-36. doi: 10.1097/MCG.0b013e318297fb10.
Results Reference
background
PubMed Identifier
1858087
Citation
Chinn S. Statistics in respiratory medicine. 2. Repeatability and method comparison. Thorax. 1991 Jun;46(6):454-6. doi: 10.1136/thx.46.6.454. No abstract available.
Results Reference
background
PubMed Identifier
884196
Citation
Landis JR, Koch GG. An application of hierarchical kappa-type statistics in the assessment of majority agreement among multiple observers. Biometrics. 1977 Jun;33(2):363-74. No abstract available.
Results Reference
background
PubMed Identifier
8042019
Citation
Sahi T. Genetics and epidemiology of adult-type hypolactasia. Scand J Gastroenterol Suppl. 1994;202:7-20. doi: 10.3109/00365529409091740.
Results Reference
background
PubMed Identifier
8042017
Citation
Villako K, Maaroos H. Clinical picture of hypolactasia and lactose intolerance. Scand J Gastroenterol Suppl. 1994;202:36-54. doi: 10.3109/00365529409091743.
Results Reference
background
PubMed Identifier
20186234
Citation
Suchy FJ, Brannon PM, Carpenter TO, Fernandez JR, Gilsanz V, Gould JB, Hall K, Hui SL, Lupton J, Mennella J, Miller NJ, Osganian SK, Sellmeyer DE, Wolf MA. NIH consensus development conference statement: Lactose intolerance and health. NIH Consens State Sci Statements. 2010 Feb 24;27(2):1-27.
Results Reference
background
PubMed Identifier
1186802
Citation
Newcomer AD, McGill DB, Thomas PJ, Hofmann AF. Prospective comparison of indirect methods for detecting lactase deficiency. N Engl J Med. 1975 Dec 11;293(24):1232-6. doi: 10.1056/NEJM197512112932405.
Results Reference
background
PubMed Identifier
20522486
Citation
Jellema P, Schellevis FG, van der Windt DA, Kneepkens CM, van der Horst HE. Lactose malabsorption and intolerance: a systematic review on the diagnostic value of gastrointestinal symptoms and self-reported milk intolerance. QJM. 2010 Aug;103(8):555-72. doi: 10.1093/qjmed/hcq082. Epub 2010 Jun 3.
Results Reference
background
PubMed Identifier
20404262
Citation
Shaukat A, Levitt MD, Taylor BC, MacDonald R, Shamliyan TA, Kane RL, Wilt TJ. Systematic review: effective management strategies for lactose intolerance. Ann Intern Med. 2010 Jun 15;152(12):797-803. doi: 10.7326/0003-4819-152-12-201006150-00241. Epub 2010 Apr 19.
Results Reference
background
PubMed Identifier
5922947
Citation
Newcomer AD, McGill DB. Distribution of disaccharidase activity in the small bowel of normal and lactase-deficient subjects. Gastroenterology. 1966 Oct;51(4):481-8. No abstract available.
Results Reference
background
PubMed Identifier
19878587
Citation
Hovde O, Farup PG. A comparison of diagnostic tests for lactose malabsorption--which one is the best? BMC Gastroenterol. 2009 Oct 31;9:82. doi: 10.1186/1471-230X-9-82.
Results Reference
background
PubMed Identifier
8042016
Citation
Arola H. Diagnosis of hypolactasia and lactose malabsorption. Scand J Gastroenterol Suppl. 1994;202:26-35. doi: 10.3109/00365529409091742.
Results Reference
background
PubMed Identifier
8823908
Citation
Aragon JJ, Canada FJ, Fernandez-Mayoralas A, Lopez R, Martin-Lomas M, Villanueva D. A direct enzymatic synthesis of beta-D-galactopyranosyl-D-xylopyranosides and their use to evaluate rat intestinal lactase activity in vivo. Carbohydr Res. 1996 Sep 2;290(2):209-16. doi: 10.1016/0008-6215(96)00113-9.
Results Reference
background
PubMed Identifier
17512743
Citation
Hermida C, Corrales G, Canada FJ, Aragon JJ, Fernandez-Mayoralas A. 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 Jul 15;15(14):4836-40. doi: 10.1016/j.bmc.2007.04.067. Epub 2007 May 6.
Results Reference
background
PubMed Identifier
23328304
Citation
Hermida C, Guerra P, Martinez-Costa OH, Sanchez V, Sanchez JJ, Solera J, Fernandez-Mayoralas A, Codoceo R, Frias J, Aragon JJ. Phase I and phase IB clinical trials for the noninvasive evaluation of intestinal lactase with 4-galactosylxylose (gaxilose). J Clin Gastroenterol. 2013 Jul;47(6):501-8. doi: 10.1097/MCG.0b013e318272f507.
Results Reference
background
PubMed Identifier
16754927
Citation
Lord SJ, Irwig L, Simes RJ. When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials? Ann Intern Med. 2006 Jun 6;144(11):850-5. doi: 10.7326/0003-4819-144-11-200606060-00011.
Results Reference
background
PubMed Identifier
1907710
Citation
Fryback DG, Thornbury JR. The efficacy of diagnostic imaging. Med Decis Making. 1991 Apr-Jun;11(2):88-94. doi: 10.1177/0272989X9101100203.
Results Reference
background
PubMed Identifier
19605881
Citation
Lijmer JG, Leeflang M, Bossuyt PM. Proposals for a phased evaluation of medical tests. Med Decis Making. 2009 Sep-Oct;29(5):E13-21. doi: 10.1177/0272989X09336144. Epub 2009 Jul 15.
Results Reference
background
PubMed Identifier
17938052
Citation
Van den Bruel A, Cleemput I, Aertgeerts B, Ramaekers D, Buntinx F. The evaluation of diagnostic tests: evidence on technical and diagnostic accuracy, impact on patient outcome and cost-effectiveness is needed. J Clin Epidemiol. 2007 Nov;60(11):1116-22. doi: 10.1016/j.jclinepi.2007.03.015. Epub 2007 Aug 29.
Results Reference
background
PubMed Identifier
9171790
Citation
Blanchard TK, Mackenzie R, Bearcroft PW, Sinnatamby R, Gray A, Lomas DJ, Constant CR, Dixon AK. Magnetic resonance imaging of the shoulder: assessment of effectiveness. Clin Radiol. 1997 May;52(5):363-8. doi: 10.1016/s0009-9260(97)80131-6.
Results Reference
background
PubMed Identifier
16119491
Citation
Stanko LK, Jacobsohn E, Tam JW, De Wet CJ, Avidan M. Transthoracic echocardiography: impact on diagnosis and management in tertiary care intensive care units. Anaesth Intensive Care. 2005 Aug;33(4):492-6. doi: 10.1177/0310057X0503300411.
Results Reference
background
PubMed Identifier
15813146
Citation
Blaivas M, Kuhn W, Reynolds B, Brannam L. Change in differential diagnosis and patient management with the use of portable ultrasound in a remote setting. Wilderness Environ Med. 2005 Spring;16(1):38-41. doi: 10.1580/1080-6032(2005)16[38:ciddap]2.0.co;2.
Results Reference
background
PubMed Identifier
11526253
Citation
Hobby JL, Dixon AK, Bearcroft PW, Tom BD, Lomas DJ, Rushton N, Matthewson MH. MR imaging of the wrist: effect on clinical diagnosis and patient care. Radiology. 2001 Sep;220(3):589-93. doi: 10.1148/radiol.2203001429.
Results Reference
background
PubMed Identifier
20629478
Citation
Wilt TJ, Shaukat A, Shamliyan T, Taylor BC, MacDonald R, Tacklind J, Rutks I, Schwarzenberg SJ, Kane RL, Levitt M. Lactose intolerance and health. Evid Rep Technol Assess (Full Rep). 2010 Feb;(192):1-410.
Results Reference
background
PubMed Identifier
10520848
Citation
Srinivasan U, Jones E, Weir DG, Feighery C. Lactase enzyme, detected immunohistochemically, is lost in active celiac disease, but unaffected by oats challenge. Am J Gastroenterol. 1999 Oct;94(10):2936-41. doi: 10.1111/j.1572-0241.1999.01441.x.
Results Reference
background
PubMed Identifier
7364319
Citation
Phillips AD, Avigad S, Sacks J, Rice SJ, France NE, Walker-Smith JA. Microvillous surface area in secondary disaccharidase deficiency. Gut. 1980 Jan;21(1):44-8. doi: 10.1136/gut.21.1.44.
Results Reference
background
PubMed Identifier
10706043
Citation
Kaufman SS, Lyden ER, Brown CR, Iverson AK, Davis CK, Sudan DL, Fox IJ, Horslen SP, Shaw BW Jr, Langnas AN. Disaccharidase activities and fat assimilation in pediatric patients after intestinal transplantation. Transplantation. 2000 Feb 15;69(3):362-5. doi: 10.1097/00007890-200002150-00009.
Results Reference
background
PubMed Identifier
6895202
Citation
Kirschner BS, DeFavaro MV, Jensen W. Lactose malabsorption in children and adolescents with inflammatory bowel disease. Gastroenterology. 1981 Nov;81(5):829-32.
Results Reference
background
PubMed Identifier
10547891
Citation
Van Biervliet S, Eggermont E, Carchon H, Veereman G, Deboeck K. Small intestinal brush border enzymes in cystic fibrosis. Acta Gastroenterol Belg. 1999 Jul-Sep;62(3):267-71.
Results Reference
background
PubMed Identifier
8062196
Citation
Parnes HL, Fung E, Schiffer CA. Chemotherapy-induced lactose intolerance in adults. Cancer. 1994 Sep 1;74(5):1629-33. doi: 10.1002/1097-0142(19940901)74:53.0.co;2-l.
Results Reference
background
PubMed Identifier
1269865
Citation
Bond JH, Levitt MD. Quantitative measurement of lactose absorption. Gastroenterology. 1976 Jun;70(6):1058-62.
Results Reference
background
PubMed Identifier
666944
Citation
Maxwell C. Sensitivity and accuracy of the visual analogue scale: a psycho-physical classroom experiment. Br J Clin Pharmacol. 1978 Jul;6(1):15-24. doi: 10.1111/j.1365-2125.1978.tb01676.x.
Results Reference
background
PubMed Identifier
2197679
Citation
Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
Results Reference
background
PubMed Identifier
11064655
Citation
Hobby JL, Tom BD, Todd C, Bearcroft PW, Dixon AK. Communication of doubt and certainty in radiological reports. Br J Radiol. 2000 Sep;73(873):999-1001. doi: 10.1259/bjr.73.873.11064655.
Results Reference
background
PubMed Identifier
9510594
Citation
Dixon AK. The impact of medical imaging on the physician's diagnostic and therapeutic thinking. Eur Radiol. 1998;8(3):488-90. doi: 10.1007/s003300050423. No abstract available.
Results Reference
background
PubMed Identifier
8617035
Citation
Mackenzie R, Dixon AK, Keene GS, Hollingworth W, Lomas DJ, Villar RN. Magnetic resonance imaging of the knee: assessment of effectiveness. Clin Radiol. 1996 Apr;51(4):245-50. doi: 10.1016/s0009-9260(96)80340-0.
Results Reference
background
PubMed Identifier
908147
Citation
Pitkanen E. The conversion of D-xylose into D-threitol in patients without liver disease and in patients with portal liver cirrhosis. Clin Chim Acta. 1977 Oct 1;80(1):49-54. doi: 10.1016/0009-8981(77)90262-5.
Results Reference
background
PubMed Identifier
13696269
Citation
CRANE RK. Intestinal absorption of sugars. Physiol Rev. 1960 Oct;40:789-825. doi: 10.1152/physrev.1960.40.4.789. No abstract available.
Results Reference
background
PubMed Identifier
30431582
Citation
Monsalve-Hernando C, Crespo L, Ferreiro B, Martin V, Aldeguer X, Opio V, Fernandez-Gil PL, Gaspar MJ, Romero E, Lara C, Santander C, Torrealba L, Savescu T, Hermida C. Phase IV noninferiority controlled randomized trial to evaluate the impact on diagnostic thinking and patient management and the test-retest reproducibility of the Gaxilose test for hypolactasia diagnosis. Medicine (Baltimore). 2018 Nov;97(46):e13136. doi: 10.1097/MD.0000000000013136.
Results Reference
derived
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Evaluation of LacTEST for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance
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