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

NCT06357897 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

  • Functional Constipation

Interventions

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.

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Palittiya Sintusek, Ph.D. · Chulalongkorn University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-03
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06357897 on ClinicalTrials.gov