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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Doctor Josep Trueta
Girona, Girona, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Universitario de La Princesa
Madrid, Madrid, Spain
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.
Time frame: Through study completion, up to 10 months.
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.
Time frame: Through study completion, up to 10 months.
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.
Time frame: 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.
Time frame: Through study completion, up to 10 months.
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Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain