Clinical Trial: Evaluation of LacTEST for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: VenterPharma

Current Primary Outcome: Visual Analogical Scale [ Time Frame: Through study completion, up to 10 months. ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Physician's Questionnaire [ Time Frame: Through study completion, up to 10 months. ]
    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 [ Time Frame: Through study completion, up to 10 months. ]
    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. [ Time Frame: Through study completion, up to 10 months. ]
    To assess the safety profile of both tests performed, by assessing the frecuency of treatment-related AEs.


Original Secondary Outcome: Same as current

Information By: VenterPharma

Dates:
Date Received: December 10, 2015
Date Started: October 2015
Date Completion:
Last Updated: December 27, 2016
Last Verified: December 2016