Efficacy and palatability of the developed polyethylene glycol-based formula for the treatment of children with functional constipation

doi:10.5409/wjcp.v14.i4.108854

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World Journal of Clinical Pediatrics

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2219-2808

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

Clinical Trials Study

World J Clin Pediatr. Dec 9, 2025; 14(4): 108854
Published online Dec 9, 2025. doi: 10.5409/wjcp.v14.i4.108854

Efficacy and palatability of the developed polyethylene glycol-based formula for the treatment of children with functional constipation

Duc Long Tran, Palittiya Sintusek

Duc Long Tran, Clinical Sciences Program, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand

Duc Long Tran, Faculty of Medicine, Can Tho University of Medicine and Pharmacy, Can Tho City 90000, Viet Nam

Palittiya Sintusek, Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology (TPGHAI), Division of Gastroenterology, Department of Pediatrics, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok 10330, Thailand

Author contributions: Tran DL analyzed the data and wrote the original draft; Sintusek P validated the results and made critical revisions; Tran DL and Sintusek P conceptualized, designed the methodology, and performed the research; all authors have read and approved the final manuscript.

Supported by the 90th Anniversary of Chulalongkorn University Fund (Ratchadapiseksomphot Endowment Fund) and Ratchadapiseksompotch Funds, Graduate Affairs, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand, No. GA68/028.

Institutional review board statement: This study was approved by the Institutional Review Board of Chulalongkorn University, No. 0093/67.

Clinical trial registration statement: This study is registered at ClinicalTrials.gov, No. NCT06357897.

Informed consent statement: All study participants provided informed written consent prior to study enrollment.

Conflict-of-interest statement: The authors declare no conflict of interest regarding this study.

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: Technical appendix, statistical code, and data set available from the corresponding author at palittiya.s@chula.ac.th. Participants gave informed consent for data sharing.

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: https://creativecommons.org/Licenses/by-nc/4.0/

Corresponding author: Palittiya Sintusek, MD, PhD, Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology (TPGHAI), Division of Gastroenterology, Department of Pediatrics, King Chulalongkorn Memorial Hospital, Chulalongkorn University, 254 Phyathai Road, Bangkok 10330, Thailand. palittiya.s@chula.ac.th

Received: April 25, 2025
Revised: May 28, 2025
Accepted: August 8, 2025
Published online: December 9, 2025
Processing time: 190 Days and 7.7 Hours

Abstract

BACKGROUND

Excipients may improve the palatability of polyethylene glycol (PEG), the first-line treatment for childhood functional constipation (FC), leading to good compliance and improved treatment outcomes.

AIM

To compare the developed PEG-based formula (PEG-Chula) to the commercial formula for treating childhood FC.

METHODS

In this randomized controlled trial, we enrolled children aged < 18 years with FC diagnosed by the Rome IV criteria to receive PEG-Chula [four flavors: (1) Strawberry; (2) Lychee; (3) Apple; and (4) Lychee-rose] or Forlax (orange-grapefruit flavor) for eight weeks. The primary outcomes included changes in stool frequency and consistency measured by the Bristol Stool scale. The secondary outcomes were constipation-related symptom improvement, adverse events, and palatability measured by the facial hedonic scale.

RESULTS

Fifty-two children diagnosed with FC [median age: 4.21 (2.33, 7.88) years; 35 (67.31%) females] were enrolled. After the 8-week treatment, the mean weekly stool frequency increased in both groups, the mean change was 4.02 (95%CI: 3.09–4.95) in PEG-Chula and 3.78 (95%CI: 2.79–4.78) in commercial PEG compared to baseline (P < 0.001). The extent of stool consistency improvement did not differ significantly. The most preferred PEG-Chula flavor was rated more palatable than the commercial PEG. Treatment compliance correlated with medication palatability (r = 0.34, P = 0.013). No significant differences in adverse events were found.

CONCLUSION

Both PEG-based formulas are effective and safe for managing pediatric FC.

Keywords: Constipation; Palatability; Compliance; Polyethylene glycol; Children

Core Tip: Functional constipation (FC), a common functional gastrointestinal disorder in children, affects the quality of life of these children and their families. A combination of osmotic laxatives and toilet training is essential for effective management. Although polyethylene glycol (PEG) is recommended as the first-line treatment, poor palatability often limits patient compliance. This randomized controlled trial compared a newly developed PEG-based formula with the commercialized product, with both formulas being effective and safe. A positive correlation between palatability and compliance was established. Improving taste may be the key to enhancing compliance and improving treatment outcomes in children with FC.