Department of Pediatric Gastroenterology and Nutrition
Warsaw, 02-091, Poland
NCT Number: NCT07786363
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.
Looking for future studies?
Notify Me6 year–18 year
All sexes
Interventional
Not applicable
Warsaw, 02-091, Poland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
polyethylene glycol (PEG) at a dose of 100 ml/kg of body weight (maximum 4 liters)
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.
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.
Time frame: in 10 minutes after colonoscopy
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.
Time frame: in 10 minutes after colonoscopy
time from the last dose of laxative solution to the start of the colonoscopy (in minutes)
Time frame: in the first 6 hours after colonoscopy
Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort
Time frame: in the first 6 hours after colonoscopy
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)
Time frame: in 10 minutes before the start of colonoscopy
time from the start of taking the preparation to the first bowel movement (in minutes)
Medical University of Warsaw
Other
Evaluation of the Efficacy, Tolerability, and Safety of Two Colonoscopy Preparation Regimens in Children With Inflammatory Bowel Disease: a Randomized Study.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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