Functional constipation means having trouble with bowel movements (pooping) even when no other health problem is causing it. This study looks at a medicine called linaclotide, which might help kids aged 2 to 5 with this problem. Linaclotide is a medicine already approved for adults and is now being tested for little kids. In the first part, kids have a 50% chance of getting either linaclotide or a sugar pill, known as a placebo. In the second part, all kids get linaclotide.
The study takes about 36 weeks: 12 weeks for the first part and 24 weeks for the second part. Kids will go to a hospital or clinic for check-ups, blood tests, and to see if they have any side effects. This might be more work than what they usually do for constipation. About 116 kids will join from around the world.
- It's a 36-week study with regular hospital visits.
- Participants have a 50% chance to get a placebo initially.
- Medical tests will be done to ensure safety.