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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorChulalongkorn University

About this trial

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 criteria

Qualifiers

Age from 6 months to 18 years old

Children are diagnosed with FC according to ROME IV criteria

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Local PEG4000
  • Commercial PEG4000

Treatment groups

52 Participants
are divided into 2 treatment groups

Sponsors and collaborators