RecruitingNAINTERVENTIONAL

Respiratory Dysbiosis in Preschool Children with Asthma: Predictive of a Severe Form

This study is for young children, aged 1 to 3 years old, who have asthma that isn't fully controlled by standard inhaled steroid medicines. About 1 in 10 preschool children have asthma, and for some, the usual treatments don't work as well as hoped. Researchers are investigating whether an imbalance of tiny organisms (called 'microbes') in a child's lungs and gut, known as dysbiosis, could be linked to severe asthma and make treatments less effective. They want to see if studying these microbes could help identify children who might need different or more tailored treatments in the future. The aim is to find better ways to manage severe asthma in very young children.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Brest

Enrolment target

Start

04 Feb 2022

Estimated completion

04 Feb 2028

Asthma in Children Dysbiosis

What is this study about?

Imagine your body as a tiny world filled with billions of microscopic living things, like bacteria and fungi, especially in your gut and lungs. These ‘microbes’ usually live in a balanced community, helping your body stay healthy. When this balance is disturbed, it’s called ‘dysbiosis’.

This study is looking into whether this imbalance might be playing a part in why some toddlers, aged 1 to 3 years old, have severe asthma that doesn't get much better with standard inhaled medicines. Doctors already know that about 11 to 12 children out of every 100 in this age group have asthma. For many, inhalers work well, but for some, they don’t seem to be enough.

Scientists have recently learned a lot about how these tiny bugs affect other lung conditions. They are now wondering if they can find similar patterns in young children with severe asthma. The main goal is to find out if there's a clear link between these microbial imbalances and severe asthma, and if we can find 'biomarkers' – signals from the body – that tell us this is happening. Ultimately, this could lead to more personalised and effective treatments for children with severe asthma in the future.

Key takeaways

The study is for children aged 1 to 3 with asthma.
It aims to understand why standard asthma medicines don't always work for some children.
Researchers are exploring if an imbalance of body microbes (dysbiosis) plays a role.
Tests include stool, blood, nasal swabs, and lung mucus samples.
Participation will not change your child's current asthma treatment.
The findings could lead to future personalised asthma treatments.

Who may be eligible?

This study is looking for young children between their first and third birthdays. To take part, a paediatrician (a doctor specialising in children's health) must have already diagnosed your child with asthma. Also, your child needs to be covered by the social security system, and a parent or legal guardian must agree to their participation.

There are some reasons why a child might not be able to join. This includes if they have other serious long-term health problems like certain heart conditions, immune problems, cystic fibrosis, or severe brain conditions. Children who were born very prematurely (before 34 weeks) or who have recently taken certain medications, like antibiotics in the last week or oral steroids in the last 10 days, also can't take part. Lastly, if your child has had recent surgery on their digestive system, they won't be eligible.

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 your child aged between 1 and 3 years old?
Has a children's doctor (paediatrician) diagnosed your child with asthma?
Does your child currently have asthma that isn't fully controlled by their inhaled medicines?
Has your child NOT had antibiotics in the last 7 days?
Has your child NOT had oral steroids (tablets or liquid) in the last 10 days?
Does your child NOT have other serious long-term health conditions?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will need to have a few tests. These include a stool sample (poo test) to look at the microbes in their gut, a blood test, and a nasal swab to check for viruses. They will also have a test called 'induced sputum,' which involves collecting mucus from their lungs. This test helps researchers look at the microbes in their airways. The study will not involve any new medicines; it's purely for investigation. We don't have information on the exact number of visits or the total duration of the study, but the tests mentioned are the main procedures involved.

Potential risks and benefits

Taking part in research studies helps us learn more about diseases and find better treatments for everyone. While there might not be a direct benefit to your child from taking part in this specific study, the information gathered could help many other children with asthma in the future. The tests involve standard medical procedures like blood tests, stool samples, and nasal swabs, which might cause some mild, temporary discomfort. The induced sputum test can be uncomfortable but is generally safe under medical supervision. You are free to withdraw your child from the study at any time, for any reason, without it affecting their care.

Locations (1)

CHU de Brest
Verified postcode
Brest, France· Recruiting

Common questions

What is 'dysbiosis'?

Dysbiosis is when the balance of tiny living organisms (microbes) in your body, like bacteria, gets upset. Researchers think this might affect asthma.

Will my child receive new medicine in this study?

No, this study is observational, meaning it's to gather information. Your child will not receive any new medicines as part of this research.

Is my child's asthma severe enough for this study?

This study is for children whose asthma is not well controlled with standard inhaled steroid medicines, at doses up to a certain level (200 micrograms of fluticasone equivalent).

What kind of tests will my child have?

Your child will have a stool (poo) test, a blood test, a nasal swab, and a test to collect mucus from their lungs (induced sputum).

How long will my child be in the study?

The information provided does not specify the exact duration, but it involves conducting a series of tests to collect samples.

How to find out more

Pierrick CROS

pierrick.cros@chu-brest.fr 02 98 22 36 59 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.