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
Abstract
BACKGROUND

Bowel preparation in children can be challenging.

AIM

To describe the efficacy, safety, and tolerability of sodium picosulfate, magnesium oxide, and citric acid (SPMC) bowel preparation in children.

METHODS

Phase 3, randomized, assessor-blinded, multicenter study of low-volume, divided dose SPMC enrolled children 9-16 years undergoing elective colonoscopy. Participants 9-12 years were randomized 1:1:1 to SPMC ½ dose × 2, SPMC 1 dose × 2, or polyethylene glycol (PEG). Participants 13-16 years were randomized 1:1 to SPMC 1 dose × 2 or PEG. PEG-based bowel preparations were administered per local protocol. Primary efficacy endpoint for quality of bowel preparation was responders (rating of ‘excellent’ or ‘good’) by modified Aronchick Scale. Secondary efficacy endpoint was participant’s tolerability and satisfaction from a 7-item questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations.

RESULTS

78 participants were randomized, 48 were 9-12 years, 30 were 13-16 years. For the primary efficacy endpoint in 9-12 years, 50.0%, 87.5%, and 81.3% were responders for SPMC ½ dose × 2, SPMC 1 dose × 2, and PEG groups, respectively. Responder rates for 13-16 years were 81.3% for SPMC 1 dose × 2 and 85.7% for PEG. Overall, 43.8% of participants receiving SPMC 1 dose × 2 reported it was ‘very easy’ or ‘easy’ to drink, compared with 20.0% receiving PEG. Treatment-emergent AEs were reported by 45.5% of participants receiving SPMC 1 dose × 2 and 63.0% receiving PEG.

CONCLUSION

SPMC was an efficacious and safe for bowel preparation in children 9-16 years, with comparable efficacy to PEG. Tolerability for SPMC was higher compared to PEG.

Keywords: Children; Colonoscopy; Colon cleansing; Sodium picosulfate, magnesium oxide, and citric acid; Polyethylene glycol

Core Tip: Bowel preparation selection in children should prioritize safety and tolerability, with efficacy an additional important consideration. Currently, there are no universally preferred bowel preparation regimens for children, and standardized protocols are few. Sodium picosulfate, magnesium oxide, and citric acid (SPMC) low volume bowel preparation had higher tolerability in children 9-16 years compared to polyethylene glycol (PEG)-based preparations, potentially due to a lower volume of bowel preparation to ingest. SPMC bowel preparation efficacy and safety were comparable to PEG.