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

Recruiting now · Not applicable

Conditions studied: Functional Constipation

In brief

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.

Key facts

Study ID

NCT06357897

Run by

Chulalongkorn University

People needed

52

Starts

2024-05-03

Expected to finish

2026-12-01

Last updated by the study team

2026-04-02

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Faculty of Medicine, Chulalongkorn University — Bangkok, Thailand (enrolling)

Full record on ClinicalTrials.gov

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