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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001181-26 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LacTEST | Experimental | 0,45 g of gaxilose po, once, per diagnostic test performed. |
|
| Hydrogen Breath Test | Active Comparator | 25 to 50 g of lactose po, once, per diagnostic test performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gaxilose | Drug | After gaxilose administration, urine collection, cuantification (firstly from 0 to 4 hours, and total urine from 0 to 5 hours), and xilose cuantification afterwards. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, up to 10 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, up to 10 months. |
| Intraclass Correlation Coefficient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Crespo, MD, PhD | Hospital Universitario Ramón y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain | ||
| Hospital Universitario Doctor Josep Trueta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23722657 | Background | 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. | |
| 1858087 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 17, 2017 | |
| Reset | Aug 20, 2018 | |
| Release | Sep 14, 2018 |
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|
| lactose | Dietary Supplement | After lactose administration, expired hydrogen measurement at pre-specified intervals. |
|
|
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. |
| Through study completion, up to 10 months. |
| 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. | Through study completion, up to 10 months. |
| Girona |
| Girona |
| 17007 |
| Spain |
| Hospital Universitario de Getafe | Getafe | Madrid | 28905 | Spain |
| Hospital Universitario de La Princesa | Madrid | Madrid | 28006 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid | 28034 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Málaga | 29010 | Spain |
| Background |
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| 30431582 | Derived | 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. |
| Reset | Feb 8, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 17, 2017 | Aug 20, 2018 | |||
| Sep 14, 2018 | Feb 8, 2019 |
| ID | Term |
|---|---|
| D007787 | Lactose Intolerance |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C073827 | 4-O-galactopyranosylxylose |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
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