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

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying lactose intolerance in children aged 5 to 11 years. Lactose intolerance is a condition where the body has difficulty digesting lactose, a sugar found in milk and dairy products. The study will use a treatment called LacTEST, which contains the active substance gaxilose. LacTEST is an oral solution designed to help diagnose a specific type of lactose intolerance known as hypolactasia, where the body produces low levels of the enzyme needed to break down lactose.

The purpose of the study is to evaluate how well LacTEST works in diagnosing hypolactasia in children who show symptoms of lactose intolerance. During the study, children will take LacTEST, and their urine will be collected over a period of time to measure the amount of a substance called xylose. This measurement will help determine if the child has hypolactasia or not. The study aims to confirm if a specific amount of xylose in the urine can accurately classify children as having hypolactasia or not, based on standard clinical practices.

The study will also explore different ways to improve the test, such as using different amounts of xylose or shortening the urine collection time. Additionally, the study will monitor any side effects that may occur in children taking LacTEST. The goal is to ensure that LacTEST is a reliable and safe method for diagnosing lactose intolerance in children.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be introduced to the trial procedures and objectives. The study aims to evaluate the effectiveness of LacTEST 0.45 g in diagnosing lactose intolerance in children aged 5 to 11 years.
Step 2
Medication administration
The participant will take LacTEST 0.45 g, which is a powder for oral solution. This means the medication is taken by mouth after being dissolved in a liquid.
The dosage is 0.45 grams, and it is administered once as part of the diagnostic procedure.
Step 3
Urine collection
After taking the medication, the participant will need to collect urine over a period of 5 hours. This is to measure the amount of a substance called xylose, which helps in diagnosing lactose intolerance.
The goal is to determine if the amount of xylose in the urine can accurately classify the participant as having lactose intolerance or not.
Step 4
Evaluation of results
The collected urine will be analyzed to check the level of xylose. The study will use a specific cut-off point of 19.18 mg of xylose to determine the diagnosis.
The results will help in understanding the effectiveness of LacTEST 0.45 g in diagnosing lactose intolerance under real-world conditions.
Step 5
Monitoring and follow-up
Throughout the study, any side effects or adverse events related to the use of LacTEST 0.45 g will be monitored and recorded.
The study will also explore different cut-off points and the possibility of shortening the urine collection time to 4 hours, if applicable.

Who can join the trial?

3 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 lifestyle guidelines.
Children who have symptoms of lactose intolerance.

Who cannot join the trial?

1 criterion

Patients with **lactose intolerance** cannot participate. This means if you have trouble digesting lactose, which is a sugar found in milk and dairy products, you are not eligible.

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Verified sites

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

Hospital Clinico San Carlos
Verified
Madrid, Spain
Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

Trial locations

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Investigated drugs

LacTEST is a diagnostic tool used to help identify if children aged 5 to 11 years have difficulty digesting lactose, which is a sugar found in milk and dairy products. This test measures the amount of a substance called xylose in the urine over a period of time. By doing this, it helps doctors determine if a child has a condition called hypolactasia, which means they have low levels of lactase, the enzyme needed to break down lactose. This test is important because it helps to confirm whether the symptoms a child is experiencing are due to lactose intolerance or not.

GAXILOSE

What is already known about the treatment

LacTEST – LacTEST is a diagnostic medication administered orally in the form of a tablet. It is currently being studied in a phase IV clinical trial to assess its effectiveness in real-world conditions for diagnosing lactose intolerance in children aged 5 to 11 years. The main therapeutic indication for LacTEST is to help identify children who have difficulty digesting lactose, a sugar found in milk and dairy products. At the molecular level, LacTEST works by measuring the amount of xylose, a type of sugar, in the urine after ingestion, which helps determine if a child is lactose intolerant. It is classified pharmacologically as a diagnostic agent.

Investigated diseases

Lactose intolerance – Lactose intolerance is a digestive disorder caused by the inability to digest lactose, the main sugar in milk and dairy products. This condition occurs when the small intestine does not produce enough of the enzyme lactase, which is needed to break down lactose into glucose and galactose for absorption. Symptoms typically begin 30 minutes to 2 hours after consuming lactose-containing foods and include bloating, diarrhea, and abdominal cramps. The severity of symptoms can vary based on the amount of lactose consumed and the individual's level of lactase deficiency. Over time, individuals may learn to manage their symptoms by adjusting their diet to limit or avoid lactose. Lactose intolerance is more common in certain populations and can develop at any age.