RecruitingNot ApplicableNCT06357897

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

Faculty of Medicine, Chulalongkorn University

Sponsor

Chulalongkorn University

Enrollment

52 participants

Start Date

May 3, 2024

Study Type

INTERVENTIONAL

Conditions

Functional Constipation

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.

Eligibility

Min Age: 6 MonthsMax Age: 18 Years

Inclusion Criteria3

Children will be enrolled in this study when they meet 2 criteria:
Age from 6 months to 18 years old
Children are diagnosed with FC according to ROME IV criteria

Exclusion Criteria5

Children will be excluded from the study if they meet any of the following criteria:
Having an organic cause of constipation such as anorectal malformations, Hirschsprung disease, myelomeningocele, hypothyroidism, etc.
Suspected GI obstruction
Receiving medication affecting bowel movement
Having a history of allergy to PEG and stevia.

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Interventions

DRUGLocal 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.

DRUGCommercial 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.