Macrogole Versus Sodium Picosulfate in Bowel Cleansing for Colonoscopy in Pediatric Inflammatory Bowel Disease

NCT07786363 | Completed

• 1 other identifier: PEG vs Citrafleet in IBD
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colonoscopy Preparation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

polyethylene glycol (PEG)

ACTIVE COMPARATOR

polyethylene glycol (PEG) at a dose of 100 ml/kg body weight (maximum 4 liters)

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.

Drug: Citrafleet®

Interventions

polyethylene glycol (PEG 4000) (Forlax ®) DRUG

polyethylene glycol (PEG) at a dose of 100 ml/kg of body weight (maximum 4 liters)

polyethylene glycol (PEG)

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.

Sodium picosulfate and magnesium oxide

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Pediatric Gastroenterology and Nutrition

Warsaw, 02-091, Poland

Location

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof dr hab med

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 26, 2026
• Study Start: June 1, 2023
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)