NCT06357897

The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation

Faculty of Medicine, Chulalongkorn University

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Besides, we also aim to assess the side effects of a developed PEG-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups.

Detailed description

Total 52 children age 6 months to 18 years old diagnosed with functional constipation will be enrolled in this study. They will be randomised in Group A or Group B. Children in group A will receive PEG-Chula at a dose of 0.5 - 1 g/kg/day for a duration of 56 days. Children in group B will receive the standard PEG formula (Forlax) at a dose of 0.5 - 1 g/kg/day for a duration of 56 days. PEG-Chula and standard PEG will be prepared in sachets with similar packaging and appearance labelled A, B, C, D. Children in both groups will also receive counseling on toilet training, water intake, and fiber intake in the same manner. Parents will be advised to record symptoms, dietary intake, and dose of medication in a logbook. Children will visit the researchers on days 7, 14, 28, and 56 to collect data on symptoms, stool diameter, bowel size measured by ultrasound, side effects, and medication compliance. Children with poor compliance will be excluded from the study.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DRUG	Local PEG4000	PEG-Chula is developed from PEG 4000 used at King Chulalongkorn Memorial Hospital with added sweetener and flavours. Children will be given PEG-Chula at a dose of 0.5 - 1 g/kg/day.
DRUG	Commercial PEG4000	For commercial PEG, We use Forlax as the control group. Children will be given Forlax at a dose of 0.5 - 1 g/kg/day.

Timeline

• Start date: 2024-05-03
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-04-10
• Last updated: 2026-04-02

Locations

1 site across 1 country: Thailand