Not recruiting

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

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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 trial?

4 criteria

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 trial?

3 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

GAXILOSE

What is already known about the treatment

Gaxilose – Gaxilose is administered orally in the form of a single dose, specifically as LacTEST 0.45g, and is used in a clinical trial setting to help diagnose hypolactasia, which is a condition where the body has difficulty digesting lactose. The current status of Gaxilose in medical literature is as a substance under investigation in a Phase I clinical trial aimed at establishing a urinary xylose cut-off point for diagnosing hypolactasia in children aged 5 to 11. The main therapeutic indication for Gaxilose is to aid in the diagnosis of hypolactasia by measuring the amount of xylose in urine after ingestion. At the molecular level, Gaxilose works by being broken down in the body, and the resulting xylose is excreted in the urine, which can then be measured to assess lactose digestion capability. It is classified pharmacologically as a diagnostic agent.

Investigated diseases

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.