Efficacy of linaclotide with polyethylene glycol at high risk of inadequate bowel preparation: A randomized controlled trial

doi:10.4240/wjgs.119538

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World Journal of Gastrointestinal Surgery

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1948-9366

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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Randomized Controlled Trial

Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.

World J Gastrointest Surg. Jun 27, 2026; 18(6): 119538
Published online Jun 27, 2026. doi: 10.4240/wjgs.119538

Efficacy of linaclotide with polyethylene glycol at high risk of inadequate bowel preparation: A randomized controlled trial

Wei-Min Li, Xiao-Peng Wang, Yu-Xuan Li, Yi-Dong Wang, Yi-Jie Sun, Guo-Dong Li, Jia-Qi Wu

Wei-Min Li, Xiao-Peng Wang, Yi-Jie Sun, Guo-Dong Li, Jia-Qi Wu, Department of Gastroenterology, The Affiliated Hospital of Hangzhou Normal University, Hangzhou 310000, Zhejiang Province, China

Yu-Xuan Li, School of Clinical Medicine, Hangzhou Normal University, Hangzhou 310000, Zhejiang Province, China

Yi-Dong Wang, Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310000, Zhejiang Province, China

Co-first authors: Wei-Min Li and Xiao-Peng Wang.

Author contributions: Li WM and Wang XP contributed equally to this work as co-first authors, and were primarily responsible for conceptualization, design, data collection, formal analysis and writing-original draft; Wu JQ contributed to conceptualization, design, data collection, formal analysis and writing-original draft; Li YX and Sun YJ contributed to data collection, formal analysis; Wang YD and Li GD contributed to design, formal analysis, writing-review and editing, supervision; and all authors read and approved the final manuscript.

Supported by the Hangzhou Biomedical and Health Industry Development Support Technology Special Project, No. 2023WJC080; and the Hangzhou Medical and Health Science and Technology Project, No. A20251519.

Institutional review board statement: The study was approved by the Institutional Review Board of the Affiliated Hospital of Hangzhou Normal University, No. 2023(E2)-HS-033.

Clinical trial registration statement: This trial was registered in the Chinese Clinical Trial Registry (No. ChiCTR2500111663).

Informed consent statement: All study participants were fully informed. Written informed consents were obtained from all participants.

Conflict-of-interest statement: The authors declare that they have no conflict of interest.

CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.

Data sharing statement: The datasets used in this study are available from the corresponding author on reasonable request.

Corresponding author: Jia-Qi Wu, MD, Doctor, Department of Gastroenterology, The Affiliated Hospital of Hangzhou Normal University, No. 126 Wenzhou Road, Hangzhou 310000, Zhejiang Province, China. wujiaqi_12@126.com

Received: February 2, 2026
Revised: March 11, 2026
Accepted: April 1, 2026
Published online: June 27, 2026
Processing time: 140 Days and 11.4 Hours

Abstract

BACKGROUND

Adequate bowel preparation is fundamental for colonoscopy. The traditional strategy of 3 L polyethylene glycol (PEG) is often unsatisfactory for people at high risk of inadequate bowel preparation (HR-IBP).

AIM

To evaluate bowel preparation quality and adverse events associated with 3 L PEG combined with linaclotide in the HR-IBP population.

METHODS

This single-center, endoscopist-blinded, randomized controlled trial enrolled patients scheduled for colonoscopy. A total of 167 patients were randomly allocated to either the 3 L PEG group or the 3 L PEG plus linaclotide group. The quality of bowel preparation was assessed using the Boston bowel preparation scale (BBPS). The adenoma detection rate (ADR), polyp detection rate (PDR), polyp characteristics, and adverse events were also analyzed.

RESULTS

BBPS scores were significantly higher in the 3 L PEG plus linaclotide group than in the 3 L PEG alone group (6.800 ± 1.444 vs 5.593 ± 1.579, P < 0.001). The adequate bowel preparation rate was also markedly higher in the 3 L PEG plus linaclotide group (86.250% vs 58.025%, P < 0.001). ADR, PDR, polyp characteristics, and adverse events were comparable between the groups.

CONCLUSION

The combination of 3 L PEG and linaclotide is optimal for bowel cleansing in high-risk cohorts.

Keywords: Linaclotide; Bowel preparation; High-risk patients; Boston bowel preparation scale; Adequate preparation rate

Core Tip: This randomized controlled trial evaluated the efficacy of 3 L polyethylene glycol combined with linaclotide in patients at high risk of inadequate bowel preparation. Linaclotide significantly improved bowel cleansing and the adequacy of bowel preparation. No differences were observed between the groups in adenoma detection rate, polyp detection rate, polyp characteristics, or adverse events. This novel evidence supports the use of 3 L polyethylene glycol with linaclotide for bowel cleansing in high-risk populations.