Colonoscopy PreparationNCT07786363
Macrogole Versus Sodium Picosulfate in Bowel Cleansing for Colonoscopy in Pediatric Inflammatory Bowel Disease
A study testing polyethylene glycol (PEG 4000) (Forlax ®) and Citrafleet® in people with Colonoscopy Preparation, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Children hospitalized at the Department of Pediatric Gastroenterology and Nutrition at the Medical University of Warsaw with suspected or confirmed inflammatory bowel disease (IBD) will be invited to participate in the study. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Colonoscopy Preparation
- What is being tested?
- polyethylene glycol (PEG 4000) (Forlax ®) and Citrafleet®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2023to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- suspected IBD or IBD diagnosed according to the widely accepted Porto criteria (incorporating clinical, endoscopic, and histopathological criteria);
- eligibility for colonoscopy;
- normal laboratory test results: sodium, potassium, and creatinine levels;
- informed consent from the child's parents or guardians for participation in the study; for children over 16 years of age, additional consent from the child participating in the study.
Who cannot join
- following gastrointestinal surgery;
- with renal failure or heart failure;
- with conditions other than IBD that constitute an indication for colonoscopy;
- whose parents or guardians have not consented to participation in the study; or, in the case of children over 16 years of age, lack of consent from the child.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatric Gastroenterology and Nutrition
Warsaw, 02-091
About this study
Official title: Evaluation of the Efficacy, Tolerability, and Safety of Two Colonoscopy Preparation Regimens in Children With Inflammatory Bowel Disease: a Randomized Study.
Children hospitalized at the Department of Pediatric Gastroenterology and Nutrition at the Medical University of Warsaw with suspected or confirmed inflammatory bowel disease (IBD) will be invited to participate in the study.
Data regarding demographics, current body weight, height, and the number of daily bowel movements during the week prior to the colonoscopy will be collected for each patient.
Read more
On the day before the colonoscopy, all patients will be placed on a low-residue diet until 3:00 PM. Children will be randomly assigned-based on a computer-generated randomization list-to one of two groups:
- one group will receive a high-volume polyethylene glycol (PEG)-based preparation at a dose of 100 ml/kg of body weight (maximum 4 liters),
- the other group will receive a low-volume preparation containing sodium picosulfate and magnesium oxide at the following doses: for patients ≤9 years of age, two doses of ½ sachet (150 ml total); for patients >9 years of age, two doses of 1 sachet (300 ml total); along with an appropriate volume of fluids: a minimum of 1500 ml for patients ≤9 years of age and a minimum of 3000 ml for patients >9 years of age.
The children will receive the preparations after 3:00 PM on the day before the colonoscopy. In addition to the aforementioned fluid intake, the patient may consume any amount of clear fluids; the total volume of fluids consumed will be recorded in the patient's chart.
Each patient will receive detailed written instructions outlining the individual dosage of the preparation and the colonoscopy preparation regimen. Additionally, a discussion will be held with the patient and their parent or guardian to review the preparation process and emphasize the importance of proper bowel cleansing for the quality of the examination.
The quality of bowel preparation will be assessed using the Bristol Bowel Preparation Scale (BBPS) scale by the physician performing the colonoscopy.
The patient and their parent or guardian will rate the tolerability of the colonoscopy preparation using a 10-point visual analogue scale.
In all cases, a prerequisite for inclusion in the study will be obtaining written or verbal consent from the child's parents or guardians and from any child over the age of 16, as well as from a younger child if they are capable of understanding the purpose of the study.
- Conditions
- Colonoscopy Preparation
- Being tested
- polyethylene glycol (PEG 4000) (Forlax ®), Citrafleet®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycol (PEG 4000) (Forlax ®)Drug
polyethylene glycol (PEG) at a dose of 100 ml/kg of body weight (maximum 4 liters)
Citrafleet®Drug
Sodium picosulfate and magnesium oxide at the following doses: for patients aged ≤9 years, 2 × ½ sachet (total 150 ml); for patients aged >9 years, 2 × 1 sachet (total 300 ml); plus an adequate amount of fluids: for patients aged ≤9 years, a minimum of 1500 ml; for patients aged >9 years, a minimum of 3000 ml.
| Study group | Role | What they receive |
|---|---|---|
| polyethylene glycol (PEG) | Active comparator | polyethylene glycol (PEG) at a dose of 100 ml/kg body weight (maximum 4 liters) Receives: Drug: polyethylene glycol (PEG 4000) (Forlax ®) |
| Sodium picosulfate and magnesium oxide | Active comparator | Sodium picosulfate and magnesium oxide at the following doses: for patients aged ≤9 years, 2 × ½ sachet (total 150 ml); for patients aged >9 years, 2 × 1 sachet (total 300 ml); plus an adequate amount of fluids: for patients aged ≤9 years, a minimum of 1500 ml; for patients aged >9 years, a minimum of 3000 ml. Receives: Drug: Citrafleet® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel preparation of the whole colon
Overall bowel cleansing grade on the Boston Bowel Preparation Scale (BBPS); 0-9 points; the higher the score, the better the bowel cleansing.
Measured: in 10 minutes after colonoscopy
Secondary outcomes (5)
Bowel preparation for colon sections
Boston bowel preparation score for:
the right side of the colon the transverse section of the colon the left side of the colon
assessed in the Boston Bowel Preparation Scale (BBPS); 0-9 points; the higher the score, the better the bowel cleansing.
Measured: in 10 minutes after colonoscopy
Time between the last dose of cleansing and colonoscopy
time from the last dose of laxative solution to the start of the colonoscopy (in minutes)
Measured: in 10 minutes after colonoscopy
Tolerability
Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort
Measured: in the first 6 hours after colonoscopy
Acceptability
Patient's satisfaction of bowel preparation measured by 10-point visual-analogue scale (VAS,0 points indicates very poor tolerance, 10 points indicates very good tolerance)
Measured: in the first 6 hours after colonoscopy
First bowel movement
time from the start of taking the preparation to the first bowel movement (in minutes)
Measured: in 10 minutes before the start of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Jun 2023
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy PreparationStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Banaszkiewicz, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786363
- Sponsor's protocol ID
- PEG vs Citrafleet in IBD
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy, Tolerability, and Safety of Two Colonoscopy Preparation Regimens in Children With Inflammatory Bowel Disease: a Randomized Study.
- ClinicalTrials.gov ID
- NCT07786363
- Acronym / sponsor ID
- PEG vs Citrafleet in IBD
- Conditions
- Colonoscopy Preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children hospitalized at the Department of Pediatric Gastroenterology and Nutrition at the Medical University of Warsaw with suspected or confirmed inflammatory bowel disease (IBD) will be invited to participate in the study.
Data regarding demographics, current body weight, height, and the number of daily bowel movements during the week prior to the colonoscopy will be collected for each patient.
On the day before the colonoscopy, all patients will be placed on a low-residue diet until 3:00 PM. Children will be randomly assigned-based on a computer-generated randomization list-to one of two groups:
- one group will receive a high-volume polyethylene glycol (PEG)-based preparation at a dose of 100 ml/kg of body weight (maximum 4 liters),
- the other group will receive a low-volume preparation containing sodium picosulfate and magnesium oxide at the following doses: for patients ≤9 years of age, two doses of ½ sachet (150 ml total); for patients >9 years of age, two doses of 1 sachet (300 ml total); along with an appropriate volume of fluids: a minimum of 1500 ml for patients ≤9 years of age and a minimum of 3000 ml for patients >9 years of age.
The children will receive the preparations after 3:00 PM on the day before the colonoscopy. In addition to the aforementioned fluid intake, the patient may consume any amount of clear fluids; the total volume of fluids consumed will be recorded in the patient's chart.
Each patient will receive detailed written instructions outlining the individual dosage of the preparation and the colonoscopy preparation regimen. Additionally, a discussion will be held with the patient and their parent or guardian to review the preparation process and emphasize the importance of proper bowel cleansing for the quality of the examination.
The quality of bowel preparation will be assessed using the Bristol Bowel Preparation Scale (BBPS) scale by the physician performing the colonoscopy.
The patient and their parent or guardian will rate the tolerability of the colonoscopy preparation using a 10-point visual analogue scale.
In all cases, a prerequisite for inclusion in the study will be obtaining written or verbal consent from the child's parents or guardians and from any child over the age of 16, as well as from a younger child if they are capable of understanding the purpose of the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polyethylene glycol (PEG) | Active comparator | Drug: polyethylene glycol (PEG 4000) (Forlax ®)polyethylene glycol (PEG) at a dose of 100 ml/kg body weight (maximum 4 liters) |
| Sodium picosulfate and magnesium oxide | Active comparator | Drug: Citrafleet®Sodium picosulfate and magnesium oxide at the following doses: for patients aged ≤9 years, 2 × ½ sachet (total 150 ml); for patients aged >9 years, 2 × 1 sachet (total 300 ml); plus an adequate amount of fluids: for patients aged ≤9 years, a minimum of 1500 ml; for patients aged >9 years, a minimum of 3000 ml. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- suspected IBD or IBD diagnosed according to the widely accepted Porto criteria (incorporating clinical, endoscopic, and histopathological criteria);
- eligibility for colonoscopy;
- normal laboratory test results: sodium, potassium, and creatinine levels;
- informed consent from the child's parents or guardians for participation in the study; for children over 16 years of age, additional consent from the child participating in the study.
Key exclusion criteria (4 listed)
- following gastrointestinal surgery;
- with renal failure or heart failure;
- with conditions other than IBD that constitute an indication for colonoscopy;
- whose parents or guardians have not consented to participation in the study; or, in the case of children over 16 years of age, lack of consent from the child.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyethylene glycol (PEG 4000) (Forlax ®)polyethylene glycol (PEG) at a dose of 100 ml/kg of body weight (maximum 4 liters) | Drug | polyethylene glycol (PEG) |
| Citrafleet®Sodium picosulfate and magnesium oxide at the following doses: for patients aged ≤9 years, 2 × ½ sachet (total 150 ml); for patients aged >9 years, 2 × 1 sachet (total 300 ml); plus an adequate amount of fluids: for patients aged ≤9 years, a minimum of 1500 ml; for patients aged >9 years, a minimum of 3000 ml. | Drug | Sodium picosulfate and magnesium oxide |
Primary outcome
Bowel preparation of the whole colon
Time frame: in 10 minutes after colonoscopy
Overall bowel cleansing grade on the Boston Bowel Preparation Scale (BBPS); 0-9 points; the higher the score, the better the bowel cleansing.
5 secondary outcomes
Bowel preparation for colon sections
Time frame: in 10 minutes after colonoscopy
Time between the last dose of cleansing and colonoscopy
Time frame: in 10 minutes after colonoscopy
Tolerability
Time frame: in the first 6 hours after colonoscopy
Acceptability
Time frame: in the first 6 hours after colonoscopy
First bowel movement
Time frame: in 10 minutes before the start of colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polyethylene glycol (PEG 4000) (Forlax ®) and Citrafleet® in people with Colonoscopy Preparation, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel preparation of the whole colon (time frame: in 10 minutes after colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.