A Phase 2 Dose Finding Study Evaluating the Safety and Efficacy of Linaclotide in Pediatric Subjects 6 Months to Less Than 2 Years of Age with Functional Constipation (FC).
Is your baby or toddler, aged between 6 months and just under 2 years, struggling with constipation? This study is exploring a new medicine called Linaclotide. We want to find out the best dose to help young children who have trouble pooing regularly and comfortably. The main aim is to see how safe the medicine is for this age group and if it helps them have more regular bowel movements and softer poos. We'll also be looking at whether it reduces how much they strain when trying to go to the toilet. Some children will receive the medicine, while others will get a dummy medicine (placebo) to fairly compare the results. Your family's well-being is our priority, and we're dedicated to finding gentler ways to help little ones with constipation.
At a glance
What is this study about?
This study is all about helping very young children, specifically those aged from 6 months up to their second birthday, who are experiencing something called 'functional constipation'. This basically means they have ongoing problems pooing, even though there isn't another medical reason for it. It can be really uncomfortable for little ones and worrying for parents.
We're looking at a medicine called Linaclotide. It's already used for constipation in older children and adults, but we need to check if it's safe and works well for babies and toddlers. The main purpose of this study is to find the best dose of Linaclotide for this age group that helps them go to the toilet more easily and more often, without causing many side effects. Some children will get a very low dose, some a slightly higher dose, and some will get a dummy medicine that looks the same but contains no active drug. This is a standard way to test new medicines fairly and safely.
We really want to improve the comfort and well-being of these young children. By carefully studying Linaclotide, we hope to find a new way to help toddlers and babies who are struggling with constipation, making their daily lives, and yours, a bit easier.
Key takeaways
- This study is for babies and toddlers (6 months to under 2 years old) with ongoing constipation.
- It's testing a medicine called Linaclotide to see if it's safe and helps improve bowel movements.
- Some children will receive the medicine, others a dummy medicine (placebo).
- Participation involves clinic visits and keeping a diary of your child's pooing habits.
- Your child's safety and well-being will be closely monitored.
- You can withdraw your child from the study at any time.
Who may be eligible?
This study is looking for babies and toddlers who are between 6 months old and just under 2 years old. They can be boys or girls.
The most important thing is that they have a problem with 'functional constipation'. This means they find it hard to poo regularly, or their poos are very hard, and there's no other medical explanation for it.
If your child fits this age range and has regular tummy troubles related to constipation, they might be able to take part. The full list of requirements would be discussed by the study team to make sure it's safe and right for your child.
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 6 months old and just under 2 years old?
- Does your child have ongoing problems with constipation (hard poos, infrequent poos)?
- Has a doctor said your child's constipation is 'functional' (meaning no other medical reason)?
- Are you able to bring your child to regular clinic visits?
What does participation involve?
If your child takes part in this study, it would involve several visits to the study clinic over a period of time. During these visits, the study team would check on your child's health and record how they are doing. You would be given the study medicine (either Linaclotide or the dummy medicine) to give to your child at home.
You would also be asked to keep a simple record, perhaps by filling in a diary, about your child's bowel movements. This would include how often they go to the toilet, what their poos look like (e.g., hard or soft), and if they seem to be straining. This helps us understand if the medicine is working. After the main treatment period, there will be a follow-up period to make sure your child is doing well. The study team will explain the exact schedule and what's involved in more detail.
Potential risks and benefits
Locations (4)
- —UnverifiedBulgaria
- —UnverifiedHungary
- —UnverifiedCroatia
- —UnverifiedGermany
Common questions
What is 'functional constipation'?
It means your child has ongoing trouble pooing, such as hard poos or going infrequently, without another medical condition causing it.
What is Linaclotide?
It's a medicine that helps the gut work better to make poos softer and easier to pass.
What is a 'placebo'?
A placebo is a dummy medicine that looks just like the real medicine but contains no active drug, used to compare effects fairly.
Will I know if my child gets the real medicine or the placebo?
No, initially neither you nor the study team will know. This is done to make sure the results are fair and unbiased.
How long will my child be in the study?
The study involves a period of taking the medicine and then follow-up checks. The study team will tell you the exact time commitment.
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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