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GAXILOSE

GAXILOSE, also known as LacTEST, is a diagnostic tool being evaluated in clinical trials for the diagnosis of hypolactasia (lactase deficiency) in adults and elderly patients who present with symptoms of lactose intolerance. This article explores a clinical trial that compares GAXILOSE with the traditional Hydrogen Breath Test (HBT) to determine its effectiveness, impact on patient management, and reproducibility as a diagnostic method. Understanding these clinical evaluations helps patients comprehend how this new diagnostic approach might improve the accuracy and convenience of lactose intolerance testing.

Table of Contents

What is GAXILOSE (LacTEST)?

GAXILOSE, also known as LacTEST, is a diagnostic tool used to identify hypolactasia in adults and elderly patients who show symptoms of lactose intolerance[1]. Hypolactasia is the medical term for lactase deficiency, which is the underlying cause of lactose intolerance. Lactase is an enzyme that helps your body break down lactose, the main sugar found in milk and dairy products.

Purpose of GAXILOSE

GAXILOSE is specifically designed to diagnose hypolactasia in patients who present with clinical symptoms of lactose intolerance[1]. These symptoms typically include bloating, diarrhea, abdominal pain, and gas after consuming dairy products. The test helps doctors confirm whether these symptoms are indeed caused by lactose intolerance or if another condition might be responsible.

How GAXILOSE Works

The GAXILOSE test involves a simple process that can be completed in a few hours[1]:

  1. You’ll be given 0.45 grams of gaxilose to take orally (by mouth).
  2. After taking gaxilose, your urine will be collected over a period of 5 hours.
  3. The urine is collected in two parts: first from 0 to 4 hours after taking gaxilose, and then the total urine from 0 to 5 hours.
  4. The collected urine samples are then analyzed to measure the amount of xylose (a type of sugar) that your body has produced after processing the gaxilose.

The presence and amount of xylose in your urine can indicate whether you have hypolactasia. If your body has normal levels of lactase enzyme, it will properly break down the gaxilose and produce a certain amount of xylose. If you have hypolactasia, less xylose will be detected in your urine[1].

Comparison with Other Tests

One of the main aims of clinical research on GAXILOSE is to compare its effectiveness to the Hydrogen Breath Test (HBT), which is another commonly used test for diagnosing lactose intolerance[1]. The HBT involves consuming 25 to 50 grams of lactose and then measuring the hydrogen in your breath over several hours.

Research is evaluating whether GAXILOSE is non-inferior to HBT in terms of:

  • Impact on diagnostic thinking – how it affects the doctor’s ability to diagnose hypolactasia
  • Impact on patient management – how it influences the treatment plan for patients
  • Reproducibility – whether the test gives consistent results when repeated

These comparisons are being assessed using validated methods such as Visual Analogical Scales (VAS) and physician questionnaires[1].

Safety Profile

The safety of GAXILOSE is being closely monitored during clinical trials. Researchers are recording any treatment-related adverse events (side effects) that occur during testing[1]. These events are classified using the MedDRA thesaurus, which is a standardized medical terminology used for reporting adverse events. The collected data will help establish the safety profile of GAXILOSE compared to other diagnostic tests for lactose intolerance.

Patient Experience

GAXILOSE testing is designed to be relatively simple for patients. Unlike some other diagnostic procedures, it only requires taking the medication once and collecting urine samples over a 5-hour period[1]. This makes it potentially less burdensome than tests that require multiple samples or longer monitoring periods.

If you’re experiencing symptoms that might be related to lactose intolerance, your doctor may consider using GAXILOSE as part of the diagnostic process to determine whether hypolactasia is the cause of your symptoms.

Feature GAXILOSE Test (LacTEST) Hydrogen Breath Test (HBT)
Dosage 0.45g of gaxilose orally 25-50g of lactose orally
Collection Method Urine collection (0-4 hours and 0-5 hours) Breath samples
What is Measured Xylose levels in urine Hydrogen gas in breath
Primary Study Objective Demonstrate non-inferiority of GAXILOSE compared to HBT on impact on diagnostic thinking
Secondary Objectives – Impact on patient management
– Test reproducibility (for GAXILOSE)
– Safety profile comparison
Measurement Tools – Visual Analogical Scale (VAS)
– Physician’s Questionnaire
– Intraclass Correlation Coefficient
– Adverse events monitoring
Target Population Adults and elderly patients with symptoms of lactose intolerance
Study Duration Up to 10 months

FAQ

  • What is GAXILOSE and how is it used in diagnosing lactose intolerance? GAXILOSE (also called LacTEST) is a diagnostic compound administered orally at a dose of 0.45g. After administration, urine is collected over specific periods (0-4 hours and 0-5 hours), and the xylose content is measured. This helps determine if a patient has hypolactasia (lactase deficiency), which is the underlying cause of lactose intolerance.
  • How does the GAXILOSE test compare to the traditional Hydrogen Breath Test? The clinical trial is evaluating whether the GAXILOSE test is non-inferior to the Hydrogen Breath Test (HBT) in diagnosing hypolactasia. The comparison focuses on both tests' impact on diagnostic thinking (measured through a Visual Analogical Scale) and patient management (assessed through a Physician's Questionnaire). The traditional HBT involves consuming 25-50g of lactose and measuring hydrogen in the breath.
  • What are researchers trying to learn about GAXILOSE in this clinical trial? Researchers are evaluating three key aspects: 1) Whether GAXILOSE is at least as good as the Hydrogen Breath Test for diagnosing lactose intolerance, 2) How reproducible the GAXILOSE test results are when repeated (test-retest reliability), and 3) The safety profile of GAXILOSE compared to the traditional test by monitoring adverse events during the study.
  • How is the reproducibility of GAXILOSE being measured in the trial? The reproducibility of the GAXILOSE test is being measured using the Intraclass Correlation Coefficient (ICC). This statistical measure helps determine how consistent the test results are when the same patient takes the test multiple times. The study specifically examines urine samples collected at two different intervals: 0-4 hours and 0-5 hours after GAXILOSE administration.
  • What population is being studied in this GAXILOSE clinical trial? The trial is focused on adults and elderly patients who are experiencing clinical symptoms of lactose intolerance. These are individuals who show signs that might indicate they have difficulty digesting lactose (the sugar found in milk and dairy products) due to a deficiency in the lactase enzyme (hypolactasia).

Ongoing Clinical Trials on GAXILOSE

  • Study on the Effectiveness of Gaxilose for Diagnosing Lactose Intolerance in Children Aged 5 to 11 Years

    Recruiting

    1 1 1 1
    Investigated drugs:
    Spain

  • Study on Gaxilose for Diagnosing Lactose Intolerance in Children Aged 5-11

    Not recruiting

    1 1 1
    Investigated drugs:
    Spain

Glossary

  • Hypolactasia: A condition where there is a deficiency of the enzyme lactase in the digestive system, which is needed to break down lactose (milk sugar). This is the underlying cause of lactose intolerance.
  • Lactose Intolerance: A digestive disorder caused by the inability to digest lactose, the main carbohydrate in dairy products. It results from a shortage of the enzyme lactase and can cause symptoms like bloating, diarrhea, and abdominal pain after consuming dairy.
  • GAXILOSE: The test compound used in LacTEST for diagnosing lactase deficiency. After oral administration, it's processed in the body and measured in urine to determine lactase activity.
  • LacTEST: The commercial name for the diagnostic test using gaxilose to identify hypolactasia (lactase deficiency) in patients with symptoms of lactose intolerance.
  • Hydrogen Breath Test (HBT): A traditional diagnostic test for lactose intolerance where a patient consumes lactose and then has their breath measured for hydrogen gas, which is produced when undigested lactose is fermented by bacteria in the colon.
  • Visual Analogical Scale (VAS): A measurement tool used in the study to assess the impact of diagnostic tests on physicians' diagnostic thinking. It typically involves rating something on a continuous line between two endpoints.
  • Non-inferiority: A type of clinical trial design that aims to demonstrate that a new treatment or diagnostic test is not worse than a standard treatment or test by more than a pre-specified margin.
  • Intraclass Correlation Coefficient (ICC): A statistical measure used to assess the consistency or reproducibility of quantitative measurements made by different observers measuring the same quantity, or in this case, the same test performed multiple times.
  • Reproducibility (Test-Retest): The ability of a diagnostic test to produce consistent results when repeated under identical conditions. High reproducibility indicates a reliable test.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure. In clinical trials, AEs are carefully monitored to assess safety.
  • MedDRA: Medical Dictionary for Regulatory Activities – a standardized international medical terminology used for regulatory communication in the registration, documentation, and safety monitoring of medical products.
  • Xylose: A sugar that is measured in urine samples after GAXILOSE administration to determine lactase activity in the diagnostic test.

References

  1. https://clinicaltrials.gov/study/NCT02636413