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

Sponsor
VenterPharma (Industry)
Overall Status
Completed
CT.gov ID
NCT02636413
Collaborator
(none)
1
Enrollment
6
Locations
2
Arms
12
Duration (Months)
0.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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 Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: LacTEST

0,45 g of gaxilose po, once, per diagnostic test performed.

Drug: gaxilose
After gaxilose administration, urine collection, cuantification (firstly from 0 to 4 hours, and total urine from 0 to 5 hours), and xilose cuantification afterwards.
Other Names:
  • LacTEST

    		•
    Active Comparator: Hydrogen Breath Test

    25 to 50 g of lactose po, once, per diagnostic test performed.

    Dietary Supplement: lactose
    After lactose administration, expired hydrogen measurement at pre-specified intervals.
    Other Names:
  • Hydrogen Breath Test (HBT)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analogical Scale [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.

    Secondary Outcome Measures

    1. Physician's Questionnaire [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.

    2. Intraclass Correlation Coefficient [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.

    3. Number of participants with treatment-related adverse events as assessed by the most recent version of MedDRA thesaurus. [Through study completion, up to 10 months.]

      To assess the safety profile of both tests performed, by assessing the frecuency of treatment-related AEs.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Adults of either sex, between 18 and 70 years old.

    2. Capacity for understanding and giving the informed consent to participate in this study.

    3. 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:

    1. Pregnant women or breast-feeding women.

    2. Unable or reticent to give the informed consent or to comply with the study requirements.

    3. Patients with glomerular filtration rate (GFR) less than 90 ml/min/1.73m2.

    4. Portal hypertension: ascites, cirrhosis.

    5. Medical records of total gastrectomy and/or vagotomy.

    6. Patients diagnosed with myxedema.

    7. Patients with Diabetes Mellitus.

    8. Patients who are participating or have participated in any clinical trial within the 3 months previous to their inclusion in the study.

    9. Patients who are drug abuse consumers.

    10. Patients under treatment with antibiotics, sulphamides and antiparasitics, who cannot suspend the treatments 7 days prior to the performance of the hydrogen breath test.

    11. Patients with any recognized and already existing disorder that might interfere with the any of the lactose intolerance diagnosis tests.

    12. Patients who have taken aspirin of indomethacin in the 48h preceding the performance of the Gaxilose test.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario Marqués de Valdecilla Santander Cantabria Spain 39008
    2 Hospital Universitario de Getafe Getafe Madrid Spain 28905
    3 Hospital Universitario Doctor Josep Trueta Girona Spain 17007
    4 Hospital Universitario de La Princesa Madrid Spain 28006
    5 Hospital Universitario Ramón y Cajal Madrid Spain 28034
    6 Hospital Universitario Virgen de la Victoria Málaga Spain 29010

    Sponsors and Collaborators

    • VenterPharma

    Investigators

    • Principal Investigator: Laura Crespo, MD, PhD, Hospital Universitario Ramón y Cajal

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    VenterPharma
    ClinicalTrials.gov Identifier:
    NCT02636413
    Other Study ID Numbers:
    • VPH-GXL-2013-01
    • 2015-001181-26
    First Posted:
    Dec 21, 2015
    Last Update Posted:
    Dec 28, 2016
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Lactose Intolerance

    Study Results

    No Results Posted as of Dec 28, 2016