Evaluation of the Efficacy, Tolerability, and Safety of Two Colonoscopy Preparation Regimens in Children With Inflammatory Bowel Disease: a Randomized Study.
Sponsor study identifier
interventional
125
1 country
1
Study Start
June 1, 2023
Actual (reported)Primary Completion
October 10, 2025
Actual (reported)Study Completion
October 10, 2025
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 10, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2023
Actual (reported)October 10, 2025
Actual (reported)October 10, 2025
Actual (reported)August 14, 2026
Actual (reported)August 26, 2026
Actual (reported)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.
in 10 minutes after colonoscopy
Bowel preparation for colon sections
in 10 minutes after colonoscopy
Time between the last dose of cleansing and colonoscopy
in 10 minutes after colonoscopy
Tolerability
in the first 6 hours after colonoscopy
Acceptability
in the first 6 hours after colonoscopy
First bowel movement
in 10 minutes before the start of colonoscopy
polyethylene glycol (PEG) at a dose of 100 ml/kg 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.
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.
Department of Pediatric Gastroenterology and Nutrition
Warsaw, 02-091, Poland
125 participants (actual enrollment reported by the registry).
First Submitted
August 14, 2026
First Posted
August 26, 2026
Study Start
June 1, 2023
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 10, 2025
Actual (reported)Study Completion
October 10, 2025
Actual (reported)Last Updated
August 26, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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