A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy

This study is looking for children and teenagers between 1 and 17 years old who need to have a colonoscopy. To join, they need to weigh at least 10 kg, and if they're under 4, their weight should be healthy for their age. Girls who might get pregnant will need a negative pregnancy test and must use effective contraception during the study. Breastfeeding mothers cannot take part.

There are also some reasons why someone might not be able to join. For example, if they've had severe constipation recently, or have certain stomach or bowel conditions like a blockage or severe untreated inflammatory bowel disease. People with certain heart problems, a specific blood disorder called G6PD deficiency, or a history of significant stomach or bowel surgeries also can't participate. If someone is allergic to any of the ingredients in the study medicines, or has regularly used laxatives recently, they also won't be able to take part.

If you join this study, your child will be randomly assigned to receive either PLENVU® or sodium picosulfate. This means it's like a coin toss – you won't get to choose which one your child receives. Both medicines will be taken over two days, in what's called a 'split dose' regimen, meaning doses are taken at different times.

Your child will spend two days and one night at a special clinic called a Clinical Research Unit (CRU). They'll be admitted on Day 1, take the study medicine on both Day 1 and Day 2, and then have their colonoscopy on Day 2. After the colonoscopy and once the doctors have checked how well their bowel was cleaned, they'll be able to go home on Day 2. About a week later (around Day 9), someone from the study team will contact you for a safety check-up, either by phone or with another short visit.