A randomized double-blind placebo-controlled study to demonstrate the efficacy of PMBL® sublingual tablets in reducing the incidence of respiratory tract infections in children aged 3-12 years (PIRTIK).
This study is investigating a new tablet, called PMBL®, that dissolves under the tongue. Its main goal is to see if it can help children aged 3 to 12 get fewer respiratory tract infections, like colds or chest infections. Researchers will compare children who take the PMBL® tablet with those who take a dummy tablet (placebo), so we can understand if PMBL® really makes a difference. The study wants to find out if children get sick less often, how long their infections last, and if they need fewer antibiotics. This kind of research helps doctors understand better ways to keep children healthy.
At a glance
What is this study about?
Respiratory tract infections, like common colds, flu, and chest infections, are very common in children. They can make kids feel unwell and often mean parents have to take time off work or visit the doctor. This study is testing a new tablet, called PMBL®, which you place under the tongue to dissolve. We want to see if taking this tablet can help reduce how often children aged 3 to 12 get these kinds of infections.
To make sure the results are fair and accurate, this study is set up in a special way. Some children will receive the PMBL® tablet, while others will receive a 'dummy' tablet called a placebo. Neither the child, their parents, nor the doctors will know who is getting which tablet. This helps us to see if PMBL® actually works, rather than children getting better just because they are expecting to.
The main thing we want to find out is whether children taking PMBL® get fewer infections overall. We'll also be looking at other important things, like how long their infections last, if they need less medicine, and how many days parents might miss from work because of their child's illness. All this information will help us understand if PMBL® could be a useful way to support children's health.
Key takeaways
- Tests a new tablet (PMBL®) for children aged 3-12.
- Aims to see if PMBL® reduces breathing infections.
- Compares PMBL® to a dummy tablet (placebo).
- Study lasts for seven months (3 months treatment, 4 months follow-up).
- Focuses on how often kids get sick and how long infections last.
- Helps understand better ways to keep children healthy.
Who may be eligible?
This study is open to both boys and girls who are between 3 and 12 years old.
While the basic age and gender requirements are broad, there will be more specific criteria to ensure the study is safe and the results are reliable. For example, children with certain existing health conditions or those taking particular medications might not be able to join. These details would be checked by the study team.
If you are interested in your child participating, the study team will ask you some questions about their health to see if they meet all the necessary 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 your child between 3 and 12 years old?
- Does your child have frequent respiratory infections?
- Is your child generally in good health otherwise?
- Is your child not currently in another medical research study?
- Are you able to attend clinic visits or complete regular follow-ups for 7 months?
What does participation involve?
If your child takes part in this study, they would take either the PMBL® tablet or a dummy tablet (placebo) every day for three months. After this, the study team will continue to follow your child for another four months to see how they are doing. This means the full study period for your child would be about seven months.
Throughout these seven months, you would keep track of how many respiratory infections your child gets. The study team would provide you with a way to record this information. They would also ask about things like how long each infection lasts, if your child needed any antibiotics, and if you had to visit the doctor because of an infection. You may also be asked about any days you might have missed from work due to your child's illness. There would likely be a few visits to the clinic or phone calls with the study team to check on your child's progress and collect information.
Potential risks and benefits
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Common questions
What is a 'respiratory tract infection'?
These are common infections in your nose, throat, airways, or lungs, like colds, flu, and chest infections.
What does 'sublingual tablet' mean?
It means the tablet is placed under the tongue and dissolves there, rather than being swallowed whole.
What is a 'placebo'?
A placebo is a dummy tablet that looks exactly like the study medicine but doesn't contain any active ingredients. It helps us see if the real medicine is effective.
Will I know if my child is taking the real tablet or the placebo?
No, neither you, your child, nor the study doctors will know. This is to ensure the study results are unbiased.
How long would my child be involved in the study?
Your child would take the study tablet for three months, and then be followed for another four months, making a total of seven months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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