#1 Clinical Trials Search in Europe

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

1 1 1

What is this study about?

This clinical trial is focused on studying a condition known as hypolactasia, which is a reduced ability to digest lactose, a sugar found in milk and dairy products. The trial will use a treatment called Gaxilose, which is administered as an oral solution known as LacTEST. The purpose of the study is to determine a specific level of a substance called xylose in urine that can help diagnose hypolactasia in children aged 5 to 11 years.

During the study, participants will receive a single dose of Gaxilose. The trial is designed to be double-blind and randomized, meaning neither the participants nor the researchers will know who is receiving the actual treatment or a placebo. The study will monitor the amount of xylose excreted in the urine over a few hours after taking the dose. This will help establish a cut-off point for diagnosing hypolactasia.

In addition to measuring urinary xylose levels, the study will also observe any side effects or changes in health indicators, such as laboratory test results and vital signs, in participants who receive Gaxilose compared to those who receive a placebo. The trial aims to ensure the safety and effectiveness of using Gaxilose for diagnosing hypolactasia in children.

1 initial visit

Upon joining the study, the participant will attend an initial visit. During this visit, the participant’s parent or legal guardian will confirm their willingness to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations, and other study procedures.

The participant will be assessed to ensure they are in good health, with no baseline gastrointestinal conditions, and regularly consume lactose-containing products without signs or symptoms of intestinal lactase deficiency.

2 administration of medication

The participant will receive a single dose of Gaxilose (LacTEST 0.45 g) in the form of an oral solution. This medication is taken by mouth.

3 urine sample collection

After taking the medication, urine samples will be collected at specific intervals: 0-3 hours, 3-4 hours, and 4-5 hours. These samples will be analyzed to measure the amount of xylose excreted in the urine.

4 monitoring and follow-up

The participant will be monitored for any adverse events or changes in health status. This includes checking for any abnormal changes in laboratory test results and vital signs.

The study aims to determine the urinary xylose cut-off point for diagnosing hypolactasia in children aged 5-11 years.

Who Can Join the Study?

  • Children who are either male or female and are between 5 and 11 years old.
  • The child’s parent(s) or legal guardian(s) must be willing and able to follow all the study requirements, including visits, treatment plans, tests, and other procedures.
  • Children must be in good health and should not have any existing stomach or intestinal problems.
  • Children should regularly eat or drink products that contain lactose (a type of sugar found in milk) and should not have any signs or symptoms that suggest they might have trouble digesting lactose. This will be checked during the initial visit.

Who Cannot Join the Study?

  • Children who are not between the ages of 5 and 11 cannot participate.
  • Children who have any medical condition other than hypolactasia cannot participate. Hypolactasia is a condition where the body has difficulty digesting lactose, a sugar found in milk and dairy products.
  • Children who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection, like those with certain health conditions or disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Felildttl Padx Lm Iuopldljphcrz Bwkmwkump Dky Hwenkxkn Uywisgndavxsh Lu Pmv Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
17.04.2023

Trial locations

Investigated drugs:

Gaxilose is a medication used in this clinical trial to help diagnose a condition called hypolactasia, which is a reduced ability to digest lactose, the sugar found in milk. In this study, children between the ages of 5 and 11 are given a single dose of Gaxilose. The purpose is to measure the amount of a substance called xylose in their urine. By doing this, doctors can determine if the child has hypolactasia. This test helps to find out if the child’s body is not breaking down lactose properly, which can cause stomach problems when they consume dairy products.

Hypolactasia – Hypolactasia is a condition characterized by a reduced ability to digest lactose, a sugar found in milk and dairy products. This occurs due to a deficiency of lactase, an enzyme produced in the small intestine. As a result, undigested lactose passes into the colon, where it is fermented by bacteria, leading to symptoms such as bloating, diarrhea, and abdominal pain. The severity of symptoms can vary depending on the amount of lactose consumed and the level of lactase deficiency. Hypolactasia is more common in adults and can develop over time as lactase production decreases with age. It is important to note that this condition is different from lactose intolerance, which refers to the symptoms experienced due to hypolactasia.

Trial ID:
2023-504232-18-00
Protocol code:
VPH-GXL-2022-511
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • 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