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

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

Interventions

DRUG

polyethylene glycol (PEG 4000) (Forlax ®)

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

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.

Sponsors & Collaborators

• Medical University of Warsaw

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-01

Primary Completion

2025-10-10

Completion

2025-10-10

Countries

• Poland

Study Locations