Amphia Hospital
Breda, The Netherlands
Recruiting
A study comparing macrogol 3350 combination and sodium picosulfate for bowel cleansing before colonoscopy in children and teenagers with colonic disease
Fast replyRegistered drug
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
This study is looking at children and teenagers who need to have a colonoscopy, which is a procedure where a doctor uses a special camera to look inside the large intestine. Before this procedure can be done, the bowel needs to be completely cleaned out so the doctor can see clearly. The study will test a bowel cleansing medicine called PLENVU, which contains ascorbic acid, sodium ascorbate, potassium chloride, sodium chloride, and macrogol 3350, and compare it to another bowel cleansing medicine called sodium picosulfate. Both medicines are mixed with water to make a drink that helps empty the bowel. The study will include children and teenagers from 1 year old up to 18 years old who weigh at least 10 kilograms and need to have a colonoscopy for any reason related to colonic disease, which means any condition affecting the large intestine.
The main goal of the study is to see how well each medicine cleans the bowel by measuring the cleanliness using a scoring system called the Boston Bowel Preparation Scale. The study will also look at how well children can follow the instructions for taking the medicine, how easy it is to drink, how it tastes, and whether children experience any unwanted effects from the medicine. Participants will be randomly assigned to receive either PLENVU or sodium picosulfate, meaning it will be decided by chance which medicine they get, similar to flipping a coin. The doctor performing the colonoscopy will not know which medicine the child received, which helps make the comparison fair.
During the study, children will take the bowel cleansing medicine at home before coming to the hospital or clinic for their colonoscopy. They or their parents will keep track of how much of the medicine they were able to drink and answer questions about how they felt while taking it. The colonoscopy will be performed as planned, and the doctor will score how clean the bowel is. After the colonoscopy, there will be a follow-up period to check on the child's safety and well-being. The study is expected to start enrolling participants in early 2026 and finish in early 2027.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- The participant must be between 1 and 17 years old at the first visit.
- The participant or their parent or legal guardian must be able to keep accurate records of the participant's health information at home.
- The participant must need a colonoscopy, which is a procedure where a doctor examines the inside of the large intestine using a flexible tube with a camera.
- The participant must weigh at least 10 kilograms. If the participant is between 1 and 3 years old, they must be above the 10th percentile for weight according to standard growth charts.
- Both male and female participants can take part in the study.
- Female participants who could become pregnant must have a negative pregnancy test within 24 hours before taking the study medicine.
- Female participants who could become pregnant must use a highly effective birth control method from the start of the study until the follow-up period ends.
- Female participants who could become pregnant must not be breastfeeding.
- Male participants who are sexually active must use condoms from the start of the study until the follow-up period ends.
- Written permission must be obtained from the participant and their parent or legal guardian before any study activities begin. The study will be explained in language they can understand.
- The participant must be able to eat regular solid food or drink from a bottle or cup without breastfeeding.
- If needed, a parent or caregiver must be available to help with study visits, follow the treatment plan, attend laboratory tests, and provide information about the participant during scheduled visits.
Who cannot join the trial?
3 criteria
- The study document does not list specific reasons why patients cannot participate in this clinical trial
- If you are considering participation in this study about bowel cleansing (cleaning the intestines before a medical examination), the research team will need to review your individual medical situation to determine if you can take part
- This study involves children and teenagers from 1 year old up to 18 years old who need a procedure called colonoscopy (a test where a doctor uses a camera to look inside the large intestine)
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Verified Responsive Semmelweis University
Budapest, HungaryResponsive Universita Degli Studi Di Roma La Sapienza
Rome, Italy
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
RecruitingNot finding your country?
Not sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
PLENVU
is a bowel cleansing medication used to clean out the colon before a colonoscopy procedure. It helps clear the intestines so doctors can see the inside of the colon more clearly during the examination.
Sodium picosulfate
is another bowel cleansing medication that works as a laxative to empty the bowels before a colonoscopy. It stimulates the intestines to help remove waste so the colon can be properly examined.
What is already known about the treatment
PLENVU
PLENVU is a bowel cleansing medication taken by mouth as a liquid solution to prepare the intestines before a colonoscopy examination. It works by drawing water into the bowel through a process called osmosis, which softens the stool and increases bowel movements to thoroughly clean the colon. This medication belongs to a class of drugs called osmotic laxatives and is currently being studied in clinical trials to evaluate its effectiveness and safety in children and teenagers aged 1 to 17 years. PLENVU is used to ensure the bowel is completely clean so doctors can properly examine the inside of the colon during the procedure.
Sodium Picosulfate
Sodium picosulfate is a bowel cleansing medication taken orally as a liquid preparation to empty and clean the intestines before colonoscopy procedures. It works by stimulating the nerves in the bowel wall, which increases muscle contractions and speeds up the movement of stool through the intestines, while also preventing water absorption to keep stools soft. This medication is classified as a stimulant laxative and is an established treatment used in medical practice for bowel preparation in both adults and children. In this clinical trial, it serves as the comparison treatment to evaluate how well PLENVU works in pediatric patients.
Investigated diseases
Colonic Disease – Colonic disease refers to a group of conditions affecting the colon, which is the large intestine. These conditions can involve inflammation, structural abnormalities, or functional problems in the colon. Symptoms may include abdominal pain, changes in bowel habits, bloating, and digestive discomfort. The progression varies depending on the specific type of colonic condition present. Some colonic diseases may cause ongoing symptoms that affect daily activities and quality of life. Proper bowel preparation is often necessary for examination and evaluation of the colon.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2025-522046-42-00Protocol codeNER1006-01/2025Estimated enrolment272 patientsSponsorNorgine Limited
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?