Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase I, Single-Centre, Double-Blind, Randomized, Placebo-Controlled Clinical Trial To Determine Urinary Xylose Cut-Off Point For The Diagnosis Of Hypolactasia, After A Single Dose Of Gaxilose in Children Between 5 – 11 Years Of Age.

This study is investigating a new and easier way to diagnose lactose intolerance, a common condition where people have difficulty digesting milk sugar. It focuses on children aged 5 to 11. Participants will be given a drink containing a special sugar called Gaxilose. Researchers will then collect urine samples over a few hours to measure how much of another sugar, xylose, is present. By doing this, the study aims to find the exact levels of xylose in urine that can accurately tell if a child has lactose intolerance. This is a "Phase I" study, meaning it's an early step to make sure the test is safe and to find the best way to use it, rather than testing its effectiveness as a treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Venter Pharma S.L.

Enrolment target

Start

16 Jun 2023

Hypolactasia

What is this study about?

This research is looking for a better way to diagnose a common problem called hypolactasia, which is the medical term for lactose intolerance. When someone has lactose intolerance, their body struggles to break down a sugar found in milk and dairy products. This can lead to tummy aches, bloating, and other uncomfortable symptoms after eating dairy.

Currently, diagnosing lactose intolerance can sometimes involve procedures that are a bit more involved. This study is exploring a simpler test for children aged 5 to 11. They'll drink a special liquid called Gaxilose. This liquid contains a sugar called xylose which the body processes in a specific way. The researchers will then collect urine samples to measure how much of this xylose sugar is passed out of the body. By doing this, they hope to figure out the exact 'cut-off point' – that is, what amount of xylose in the urine can reliably tell doctors if a child has lactose intolerance.

This is an early-stage study, often called a 'Phase I' trial. This means the main goals are to make sure the test is safe, understand how the body handles the Gaxilose, and find the best way to use it for diagnosis. The study is "double-blind," which means neither the children, their families, nor the study team will know if a child receives the Gaxilose or a 'dummy' drink (called a placebo). This helps to keep the results fair and unbiased. The findings from this study could lead to a less invasive and more comfortable way to diagnose lactose intolerance in children in the future.

Key takeaways

This study explores a new, simpler way to test for lactose intolerance in children.
It involves a special drink (Gaxilose) and collecting urine samples.
The goal is to find accurate 'cut-off' levels from urine to diagnose the condition.
It's an early-stage (Phase I) study, checking safety and best use of the test.
Participation involves a visit to a hospital in Getafe, Spain.
The study aims to improve diagnosis for children aged 5-11.

Who may be eligible?

This study is open to both boys and girls. The original information doesn't specify an age range, but the trial title says children between 5 and 11 years of age. If you're considering this study for a child, it's important to confirm the exact age requirements with the study team.

Generally, clinical trials have other specific requirements to ensure that it's safe for participants to join and that the study can collect clear results. These might include things like the child's general health, any other medical conditions they have, or medications they are currently taking.

To find out if a child would be able to take part, you would need to speak directly with the study doctors or nurses. They will ask some questions about the child's health and might do a few simple checks to see if they fit all the study requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child between 5 and 11 years old?
Is my child generally healthy?
Are we able to travel to the Hospital Universitario de Getafe in Spain?
Am I comfortable with my child giving multiple urine samples over a few hours?
Does my child not have any other major health conditions or take medications that might interfere with the study?

Answer every question to see your result.

What does participation involve?

If a child takes part in this study, they will visit a hospital in Getafe, Spain. They will be given a drink, either the special Gaxilose liquid or a dummy drink (placebo). Over the next few hours, several urine samples will be collected. These samples will be analyzed in a laboratory at the hospital. The study will also keep an eye on how the child feels, checking for any side effects and monitoring basic health signs like heart rate and blood pressure. We don't know the exact number of visits or how long the total study participation will last from the information given, but it appears to be focused on a single day for the main part of the test.

Potential risks and benefits

Taking part in this study could potentially help advance our understanding of how to diagnose lactose intolerance more easily in children. While the exact benefits to an individual child are not guaranteed, they would be helping scientists discover better diagnostic methods for many children in the future. As with any study, there are potential risks, such as experiencing mild side effects from the study drink or the inconvenience of collecting urine samples. All known risks will be fully explained before anyone agrees to participate, and importantly, you have the right to withdraw from the study at any time, for any reason, without it affecting your child's medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is lactose intolerance?

Lactose intolerance means your body has trouble digesting lactose, a sugar found in milk and dairy products. This can cause tummy upset, bloating, and gas.

What is Gaxilose?

Gaxilose is a special liquid containing a sugar called xylose. It's used in this study to help doctors find a new way to test for lactose intolerance.

Will my child know if they are getting the real test or a dummy drink?

No, this is a 'double-blind' study, meaning neither you, your child, nor the study team will know if they receive Gaxilose or a dummy drink. This helps make the results fair.

What happens during the study visit?

Your child will drink a liquid, and then urine samples will be collected over several hours. Their general health signs will also be monitored.

Is this study meant to treat lactose intolerance?

No, this is a research study focused on finding a better way to diagnose lactose intolerance, not to treat it. It's an early-stage test focusing on the diagnostic method itself.