A study comparing macrogol 3350 combination and sodium picosulfate for bowel cleansing before colonoscopy in children and teenagers with colonic disease

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What is this study about?

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.

1 Screening and consent

Before any study activities begin, the study doctor or designated person will provide information about the study in language that is easy to understand.

Written consent will be obtained from your legal guardian if required by local regulations, and your agreement (assent) will be obtained when applicable.

During the screening visit, your age, weight, and general health will be checked to determine if you meet the study requirements.

If you are female and have started menstruation or are 8 years of age or older, a pregnancy test will be performed within 24 hours before receiving the bowel cleansing medicine. The test must be negative to participate.

Your weight must be at least 10 kilograms. If you are between 1 and 4 years of age, your weight must be above the 10th percentile for your age according to standard growth charts.

2 Preparation before colonoscopy

You will be randomly assigned to receive one of two bowel cleansing medicines: either PLENVU or sodium picosulfate.

Both medicines are taken by mouth (oral route) and are used to clean the bowel before a colonoscopy, which is an examination of the large intestine using a camera.

Your legal guardian or caregiver will help maintain a take-home record that includes information about your general health and how you take the medicine.

You must be able to eat regular solid food or drink from a bottle or cup without breastfeeding during the study.

3 Taking the bowel cleansing medicine

If you receive PLENVU, it will be prepared as a powder that is mixed with water to create a solution for drinking. The medicine contains ascorbic acid (vitamin C), sodium ascorbate, potassium chloride, sodium chloride (salts), and macrogol 3350 (a substance that helps clean the bowel).

If you receive sodium picosulfate, this medicine is also taken by mouth.

Your legal guardian or caregiver will record how well you follow the treatment instructions to measure compliance, which means how completely you take the medicine as directed.

The specific dosage, frequency, and duration of taking the medicine will be determined by the study doctor based on your age and weight.

4 Reporting your experience

You or your legal guardian will be asked to complete questionnaires about how easy or difficult it was to take the medicine (tolerability), how the medicine tasted (palatability), and your overall opinion about using the medicine (acceptability).

These questionnaires use a rating system called a Likert Scale, which allows you to indicate your level of agreement or disagreement with statements about your experience.

5 Colonoscopy procedure

After taking the bowel cleansing medicine, you will undergo the colonoscopy examination as planned.

During the colonoscopy, the doctor performing the procedure will assess how well your bowel was cleaned using two different rating systems: the Boston Bowel Preparation Scale (BBPS) and the Harefield Cleansing Scale (HCS).

The doctor performing the colonoscopy will not know which bowel cleansing medicine you received (colonoscopist-blind), which helps ensure an unbiased assessment.

6 Safety follow-up period

After the colonoscopy, you will be monitored for safety during a follow-up period.

If you are female and of childbearing potential, you must continue using a highly effective method of contraception (birth control with less than 1% failure rate per year) throughout this follow-up period.

If you are male and sexually active, you should use condoms throughout the follow-up period.

Your legal guardian or caregiver may need to accompany you to scheduled visits and provide information about your health using rating scales if required by local regulations or deemed necessary by the study doctor.

Who Can Join the Study?

  • 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 Study?

  • 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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital Infantil Universitario Nino Jesus Madrid Spain
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Isala Klinieken Stichting Zwolle The Netherlands
Amphia Hospital Breda The Netherlands
Area Sanitaria De Ferrol Ferrol Spain
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Uniwersytecki Szpital Dzieciecy W Krakowie Cracow Poland
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu Torun Poland
Azienda Ospedaliera Santobono Pausilipon Naples Italy
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Regensburg Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Semmelweis University Budapest Hungary
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
CHC MontLegia Liege Belgium
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej Bialystok Poland
Vrije Universiteit Brussel Jette Belgium
Servei De Salut De Les Illes Balears Palma Spain
Hospital Da Luz S.A. Lisbon Portugal
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Heim Pal Orszagos Gyermekgyogyaszati Intezet Budapest Hungary
Universita Degli Studi Di Messina Messina Italy
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Hwzjlcwr Uxqxrgvwpnuxd Rzvfuxnu Dx Moiajm Malaga Spain
Ppcq Tgysl Hbxwfggp Uexceikworkp Sabadell Spain
Aukgzugfj Uth Amsterdam The Netherlands
Utduxztidlrfqtgwdqovg Mamuwaca Arp Munster Germany
Uociykzuru Os Atklbln Edegem Belgium
Aywzyhl Oasxcabryyi Pubu Garcecka Xkucm Bergamo Italy
Umtoaznxcv Dxpkq Skhqa Dc Rlsr Lb Snmplenq Rome Italy
Cdavqk Hiruyxpzpc E Uuksaewhtnqjg Dd Cmmlpem Edgufu Coimbra Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
02.02.2026
Germany Germany
Recruiting
02.02.2026
Hungary Hungary
Recruiting
02.02.2026
Italy Italy
Recruiting
02.02.2026
Poland Poland
Recruiting
02.02.2026
Portugal Portugal
Not yet recruiting
02.02.2026
Spain Spain
Recruiting
02.02.2026
The Netherlands The Netherlands
Recruiting
02.02.2026

Trial locations

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.

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 ID:
2025-522046-42-00
Protocol code:
NER1006-01/2025
Trial Phase:
Therapeutic confirmatory (Phase III)

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