Clinical Trials Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 28, 2020; 26(40): 6260-6269
Published online Oct 28, 2020. doi: 10.3748/wjg.v26.i40.6260
Pediatric bowel preparation: Sodium picosulfate, magnesium oxide, citric acid vs polyethylene glycol, a randomized trial
Carmen Cuffari, Steven L Ciciora, Masakazu Ando, Mena Boules, Joseph M Croffie
Carmen Cuffari, Department of Pediatrics, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States
Steven L Ciciora, Department of Pediatrics, The Ohio State University College of Medicine, Colombus, OH 43205, United States
Masakazu Ando, Department of Statistics, Ferring Pharmaceuticals Inc, Parsippany, NJ 07054, United States
Mena Boules, Department of Medical Affairs, Ferring Pharmaceuticals Inc, Parsippany, NJ 07054, United States
Joseph M Croffie, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN 46202, United States
Author contributions: Ando M and Boules M were involved with study design and data analysis; Cuffari C, Ciciora SL and Croffie JM were investigators for the clinical trial; All authors analyzed and interpreted the data, drafted and critically revised the article for important intellectual content, and approved the article for publication.
Supported by Ferring Pharmaceuticals Inc.
Institutional review board statement: The study was reviewed and approved by Indiana University, Office of Research Administration, Human Subjects Office, No. 1312998338; Western IRB (Puyallup, WA), No. 1144377 and 1144701; Vanderbilt University IRB, No. 140100; Johns Hopkins Medicine; Research Institute at Nationwide Children’s Hospital, Human Subjects Committee, No. IRB14-00011; Human Research Protection Program, University of Minnesota, No. 1401M46841; The Children’s Hospital of Philadelphia IRB, No. IRB 13-010687; Chesapeake IRB (Columbia, MD), No. Pro00009776; University of California–San Diego, Human Research Protection Program, No. 150183.
Clinical trial registration statement: This registration policy applies to prospective, randomized, controlled trials only.
Conflict-of-interest statement: Dr. Cuffari participated in the speaker’s bureau for Abbott Nutrition, Abbvie, and Prometheus Laboratories.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Carmen Cuffari, MD, Associate Professor, Department of Pediatrics, The Johns Hopkins School of Medicine, 600 N Wolfe St, CMSC 2-125, Baltimore, MD 21287, United States. ccuffari@jhmi.edu
Received: May 26, 2020
Peer-review started: May 26, 2020
First decision: June 19, 2020
Revised: September 16, 2020
Accepted: September 25, 2020
Article in press: September 25, 2020
Published online: October 28, 2020
Processing time: 154 Days and 12.6 Hours
ARTICLE HIGHLIGHTS
Research background

Quality bowel preparation is a critical factor for colonoscopy success. Bowel preparation selection in children should prioritize safety and tolerability, with efficacy an additional important consideration.

Research motivation

Currently, there are no universally preferred bowel preparation regimens for children, and standardized protocols are few.

Research objectives

The objective of this study was to describe the efficacy, safety, and tolerability of sodium picosulfate, magnesium oxide, and citric acid (SPMC) low volume bowel preparation in pediatric patients 9 to 16 years old.

Research methods

A phase 3, randomized, assessor-blinded, multicenter, dose-ranging study of low volume SPMC bowel preparation or polyethylene glycol (PEG) bowel preparation. Male and female children, 9 to 16 years, who were undergoing elective colonoscopy were eligible for the study. Participants 9-12 years old were randomized 1:1:1 to SPMC ½ dose × 2, SPMC 1 dose × 2, or PEG. Participants 13-16 years old were randomized 1:1 to SPMC 1 dose × 2 or PEG. Efficacy of overall colon cleansing was assessed by the modified Aronchick scale (AS), tolerability was assessed by a 7-item questionnaire, and safety was assessed by reports of adverse events (AEs) and laboratory evaluations.

Research results

A total of 78 participants were randomized, with 48 aged 9-12 years, and 30 aged 13-16 years. In the 9-12 years group, 87.5% (90%CI: 65.6%, 97.7%) were responders for SPMC 1 dose × 2 treatment arm, and 81.3% (90%CI: 58.3%, 94.7%) were responders for PEG treatment arm. In the 13-16 yr group, 81.3% (90% CI: 58.3%, 94.7%) were responders for SPMC 1 dose × 2 treatment arm, and 85.7% (90%CI: 61.5%, 97.4%) were responders for PEG treatment arm. In the SPMC ½ dose × 2 arm (9-12 years only), 50.0% (90%CI: 27.9%, 72.1%) of participants were responders. In both age groups, a greater number of participants receiving SPMC 1 dose × 2 found it ‘very easy’ or ‘easy’ to ingest than those receiving PEG. Treatment-emergent AEs were reported by 45.5% of participants receiving SPMC 1 dose x2 and 63.0% receiving PEG.

Research conclusions

Sodium picosulfate, magnesium oxide, and citric acid low volume bowel preparation had higher tolerability in children 9-16 years compared to polyethylene glycol-based preparations, potentially due to a lower volume of bowel preparation to ingest. SPMC bowel preparation efficacy and safety were comparable to PEG.

Research perspectives

As the tolerability was higher and the efficacy and safety were consistent with the standard of care for pediatric bowel preparation, SPMC 1 dose x2 should be considered as a more feasible and easier-to-consume option compared to PEG for all bowel preparations in children 9 to 16 years old.