Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis
This research wants to understand if a specific type of bacteria found in babies' stool samples at 12 months old can help predict if they will get a lung infection caused by Pseudomonas aeruginosa by the time they are 3 years old. Pseudomonas is a common and often serious infection for people with cystic fibrosis (CF). By identifying early warning signs, doctors might be able to offer preventative treatments sooner. The study involves collecting samples like spit (expectoration), stool, and blood from babies diagnosed with CF from around 2 months old up to 3 years old, during their regular hospital visits. The aim is to find 'biomarkers' – biological clues – that could help improve care for children with CF in the future.
At a glance
What is this study about?
Cystic fibrosis (CF) is a condition that affects many parts of the body, especially the lungs. People with CF can be prone to certain infections, and one very common and troublesome bacterium is called Pseudomonas aeruginosa. This infection often leads to serious lung problems over time.
This study aims to find out if we can predict early on, in babies with CF, who might be more likely to develop this Pseudomonas infection. Researchers are particularly interested in a specific type of bacteria, Porphyromonas catoniae, which they measure when a baby is about 12 months old. They then follow these children up to 3 years old to see if this early measurement helps predict who gets the Pseudomonas infection.
The idea is that if doctors can identify children at high risk of getting Pseudomonas early, they might be able to start treatments or preventive measures sooner. This could potentially help keep children with CF healthier and slow down the progression of lung damage.
Key takeaways
- Aims to predict a common lung infection (Pseudomonas) in babies with CF.
- Looks for specific bacteria in stool samples at 12 months old.
- Involves collecting spit, stool, and blood samples during regular visits.
- Participation is during routine CF check-ups until the child is 3 years old.
- No new medicines or treatments are given during this study.
- Information gained could improve future care for children with CF.
Who may be eligible?
To take part in this study, babies must be no older than 6 months when they join. They need to have a clear diagnosis of cystic fibrosis, confirmed by specific tests. Importantly, at the time they join, they must not have had any previous Pseudomonas aeruginosa infection.
Parents or legal guardians must be able to understand French well enough for the study information. The child also needs to be part of the UK social security system. The parents or guardians will need to give their written permission for their child to take part.
Children cannot join if they have another serious illness, are having major surgery, or are unable to undergo the study's simple tests. Those on exclusive tube feeding (parenteral nutrition) are also not able to participate. If parents or guardians don't want their child to be in the study, that's perfectly fine, and their refusal will be respected.
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 baby aged 6 months or younger?
- Does my baby have a confirmed diagnosis of cystic fibrosis?
- Has my baby never had a Pseudomonas aeruginosa infection before?
- Am I able to provide consent for my child to participate?
- Is my child registered with the UK social security system?
What does participation involve?
If your child takes part, they'll join the study between 2 and 6 months old and be followed until they are 3 years old. This will mostly happen during your child's regular check-ups at the hospital.
During these visits, healthcare staff will take small samples of spit (expectoration) from your child. You will also be asked to collect stool (poo) samples from your child at home before your appointments. Once a year, a small blood sample will be taken during their annual check-up. The first few months will involve more frequent sample collections (monthly up to 6 months), then every two months until your child is one, and after that, every three months until they are three years old. There are no special medications involved in this study.
Potential risks and benefits
Locations (11)
- CHRU AngersVerified postcodeAngers, France
- Hôpital des Enfants BordeauxVerified postcodeBordeaux, France
- CHU GrenobleVerified postcodeGrenoble, France
- Hôpital Femme-Mère-Enfant LyonVerified postcodeLyon, France
- CHRU NantesVerified postcodeNantes, France
- Hôpital NeckerVerified postcodeParis, France
- Hôpital TrousseauVerified postcodeParis, France
- CHRU RennesVerified postcodeRennes, France
- Centre de PerharidyVerified postcodeRoscoff, France
- Hôpital Charles NicolleVerified postcodeRouen, France
- CHRU de ToursVerified postcodeTours, France
Common questions
What is Pseudomonas aeruginosa?
It's a common type of bacteria that can cause serious lung infections, especially in people with cystic fibrosis.
What is a 'biomarker'?
It's like a biological clue – something measurable in the body, like a type of bacteria, that can indicate a condition or risk.
Will my child receive new medicine in this study?
No, this study is about collecting samples and observations, not trying new medications.
How long will my child be in the study?
Children are followed from when they join (between 2 and 6 months old) until they are 3 years old.
What if I change my mind about my child participating?
You can withdraw your child from the study at any time, and it won't affect their medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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