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

RecruitingNAAges 6 Months - 18 YearsAllChulalongkorn University
NCT06357897 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 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 Criteria: 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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What it tests

  • Local PEG4000
  • Commercial PEG4000
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Where

1 site
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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