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

December 27, 2016 updated by: VenterPharma

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Girona, Spain, 17007
        • Hospital Universitario Doctor Josep Trueta
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • Madrid
      • Getafe, Madrid, Spain, 28905
        • Hospital Universitario de Getafe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, up to 10 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, up to 10 months.
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.
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.
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.
Through study completion, up to 10 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VenterPharma

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (Estimate)

December 21, 2015

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

December 27, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VPH-GXL-2013-01
  • 2015-001181-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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